Trial Outcomes & Findings for Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin (NCT NCT05201079)
NCT ID: NCT05201079
Last Updated: 2025-03-25
Results Overview
Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
93 participants
Primary outcome timeframe
8 weeks after the start of the treatment
Results posted on
2025-03-25
Participant Flow
First patient was recruited on 29th October 2021. Last patient was recruited on 15th November 2023. Patients were recruited in the study sites.
One selected patient was excluded before randomisation because of screening failure.
Participant milestones
| Measure |
MBK-01
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
MBK-01
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
11
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Forbidden medication
|
9
|
5
|
|
Overall Study
Transfer to another hospital
|
0
|
1
|
|
Overall Study
Clinical condition
|
1
|
0
|
|
Overall Study
SAE and sepsis
|
1
|
0
|
Baseline Characteristics
In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
Baseline characteristics by cohort
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.22 years
STANDARD_DEVIATION 17.24 • n=45 Participants
|
65.26 years
STANDARD_DEVIATION 14.65 • n=47 Participants
|
65.24 years
STANDARD_DEVIATION 15.88 • n=92 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=45 Participants
|
30 Participants
n=47 Participants
|
60 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=45 Participants
|
17 Participants
n=47 Participants
|
32 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 Participants
n=45 Participants
|
45 Participants
n=47 Participants
|
89 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Amerindian
|
1 Participants
n=45 Participants
|
0 Participants
n=47 Participants
|
1 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=45 Participants
|
1 Participants
n=47 Participants
|
1 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=45 Participants
|
1 Participants
n=47 Participants
|
1 Participants
n=92 Participants
|
|
Region of Enrollment
Spain
|
45 participants
n=45 Participants
|
47 participants
n=47 Participants
|
92 participants
n=92 Participants
|
|
Medical history: number of previous pathologies
|
7.96 previous pathologies
STANDARD_DEVIATION 4.79 • n=45 Participants
|
6.62 previous pathologies
STANDARD_DEVIATION 4.33 • n=47 Participants
|
7.27 previous pathologies
STANDARD_DEVIATION 4.58 • n=92 Participants
|
|
Medical history: number of pretreatments
|
2.33 pretreatments
STANDARD_DEVIATION 2.00 • n=45 Participants
|
2.51 pretreatments
STANDARD_DEVIATION 2.34 • n=47 Participants
|
2.38 pretreatments
STANDARD_DEVIATION 2.30 • n=92 Participants
|
|
Clostridioides difficile infection episode
Primary episode
|
25 Participants
n=45 Participants
|
28 Participants
n=47 Participants
|
53 Participants
n=92 Participants
|
|
Clostridioides difficile infection episode
Recurrent episode
|
20 Participants
n=45 Participants
|
19 Participants
n=47 Participants
|
39 Participants
n=92 Participants
|
|
Previous antibiotic treatment
Previous antibiotic · Yes
|
23 Participants
n=45 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
29 Participants
n=47 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
52 Participants
n=92 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
|
Previous antibiotic treatment
Previous antibiotic · No
|
22 Participants
n=45 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
18 Participants
n=47 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
40 Participants
n=92 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
|
Previous antibiotic treatment
Pre-washing out · Yes
|
23 Participants
n=23 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
29 Participants
n=29 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
52 Participants
n=52 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
|
Previous antibiotic treatment
Pre-washing out · No
|
0 Participants
n=23 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
0 Participants
n=29 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
0 Participants
n=52 Participants • In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed.
|
|
Duration of antibiotic treatment
|
2.96 days
STANDARD_DEVIATION 1.72 • n=23 Participants • n patients who received previous antibiotic treatment, the duration of the antibiotic treatment was analyzed.
|
3.21 days
STANDARD_DEVIATION 1.15 • n=29 Participants • n patients who received previous antibiotic treatment, the duration of the antibiotic treatment was analyzed.
|
3.08 days
STANDARD_DEVIATION 1.41 • n=52 Participants • n patients who received previous antibiotic treatment, the duration of the antibiotic treatment was analyzed.
|
|
Proton pump inhibitor treatment
Yes
|
26 Participants
n=45 Participants
|
28 Participants
n=47 Participants
|
54 Participants
n=92 Participants
|
|
Proton pump inhibitor treatment
No
|
19 Participants
n=45 Participants
|
19 Participants
n=47 Participants
|
38 Participants
n=92 Participants
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical function
|
56.90 units on a scale
STANDARD_DEVIATION 35.90 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
57.07 units on a scale
STANDARD_DEVIATION 33.71 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
56.99 units on a scale
STANDARD_DEVIATION 34.57 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical role
|
33.48 units on a scale
STANDARD_DEVIATION 33.44 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
36.55 units on a scale
STANDARD_DEVIATION 32.81 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
35.90 units on a scale
STANDARD_DEVIATION 32.96 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Bodily pain
|
52.91 units on a scale
STANDARD_DEVIATION 29.84 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
57.25 units on a scale
STANDARD_DEVIATION 29.07 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
55.18 units on a scale
STANDARD_DEVIATION 29.35 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
General health
|
55.13 units on a scale
STANDARD_DEVIATION 17.07 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
54.85 units on a scale
STANDARD_DEVIATION 20.62 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
54.98 units on a scale
STANDARD_DEVIATION 18.90 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Vitality
|
38.33 units on a scale
STANDARD_DEVIATION 11.75 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
35.69 units on a scale
STANDARD_DEVIATION 18.56 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
37.02 units on a scale
STANDARD_DEVIATION 15.74 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Social function
|
65.08 units on a scale
STANDARD_DEVIATION 15.53 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
63.77 units on a scale
STANDARD_DEVIATION 19.02 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
64.39 units on a scale
STANDARD_DEVIATION 17.36 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Emotional role
|
58.13 units on a scale
STANDARD_DEVIATION 38.98 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
68.30 units on a scale
STANDARD_DEVIATION 32.18 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
63.51 units on a scale
STANDARD_DEVIATION 35.70 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Mental health
|
54.64 units on a scale
STANDARD_DEVIATION 16.93 • n=41 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
56.06 units on a scale
STANDARD_DEVIATION 17.17 • n=46 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
55.40 units on a scale
STANDARD_DEVIATION 16.97 • n=87 Participants • SF36 Questionnaire analysis was conducted in the population that completed the questionnaire
|
|
Declared outcome of health
|
3.74 units on a scale
STANDARD_DEVIATION 1.01 • n=42 Participants • Outcome analysis was conducted on the population that completed the SF36 questionnaire
|
3.65 units on a scale
STANDARD_DEVIATION 0.97 • n=46 Participants • Outcome analysis was conducted on the population that completed the SF36 questionnaire
|
3.69 units on a scale
STANDARD_DEVIATION 0.99 • n=88 Participants • Outcome analysis was conducted on the population that completed the SF36 questionnaire
|
PRIMARY outcome
Timeframe: 8 weeks after the start of the treatmentPopulation: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 72 hours after the start of the treatmentPopulation: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 weeks after the start of the treatmentPopulation: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 3 months after the start of the treatmentPopulation: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment
|
4 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 6 months after the start of the treatmentPopulation: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks after the start of the treatmentPopulation: Out of all partipants analyzed, only 14 in the MBK-01 group and 6 in the fidaxomicin group where hospitalised due to CDI. No participant received both treatments in any case.
Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI).
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Duration of Hospitalisation
|
6.50 days
Interval 4.0 to 8.0
|
5.50 days
Interval 5.0 to 6.75
|
SECONDARY outcome
Timeframe: Up to 72 hours after the start of the treatmentPopulation: The analysis is carried out on ITT population, excluding patients with no data related to this outcome
A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors: * Increase in C-reactive protein (CRP) value (\> 5 % of the baseline value). * Increase in white blood cell count (\> 5 % of the baseline value). * Progression to sepsis: hypotension or organ failure with no other apparent cause.
Outcome measures
| Measure |
MBK-01
n=43 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=45 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Good/Bad Progress of the Patient
Worsening of the diarrhea episode
|
2 Participants
|
1 Participants
|
|
Good/Bad Progress of the Patient
Increase in white blood cell count
|
7 Participants
|
8 Participants
|
|
Good/Bad Progress of the Patient
Progression to sepsis
|
0 Participants
|
0 Participants
|
|
Good/Bad Progress of the Patient
Good progress
|
43 Participants
|
44 Participants
|
|
Good/Bad Progress of the Patient
Bad progress
|
0 Participants
|
1 Participants
|
|
Good/Bad Progress of the Patient
Increase in CRP value
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentPopulation: For the analysis of time to recurrence, there were 77 evaluable participants (37 in MBK-01 and 40 in fidaxomicin group). The reasons for non-evaluable were: MBK-01: * Non-evaluable (n=8) * Death (n=1) * Forbidden medication (n=2) * Investigator decision (n=1) * Adverse event (n=3) * Informed consent withdrawal (n=1) Fidaxomicin: * Non-evaluable (n=7): * Death (n=1) * Forbidden medication (n=2) * Investigator decision (n=1) * Adverse event (n=2) * Transfer to other hospital (n=1)
Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks.
Outcome measures
| Measure |
MBK-01
n=37 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=40 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Time to Recurrence Depending on Randomisation Groups
|
24.70 weeks
Standard Error 1.34
|
22.40 weeks
Standard Error 1.53
|
SECONDARY outcome
Timeframe: Up to 10 daysPopulation: There are 46 evaluable patients in the Fidaxomicin group because 1 patient assigned to fidaxomicin was transferred to another hospital before first administration of the treatment. No patient received both treatments under any circumstances.
Duration in days of the treatment.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=46 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Duration of Treatment
|
1.0 days
Interval 1.0 to 1.0
|
10.0 days
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentPercentage of patients that are still alive after a defined period of time from the beginning of the treatment.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Overall Survival
|
44 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentNumber of Adverse Events per randomisation group since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Number of Adverse Events Per Randomisation Group
|
89 Number of Adverse Events
|
103 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentType of Adverse Events per ramdomisation group since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: abdominal discomfort
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: abdominal pain
|
4 Number of Adverse Events
|
3 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: abdominal pain lower
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: gastrointestinal sounds abnormal
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: gastrooesophageal reflux disease
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: haemorroids
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: irritable bowel syndrome
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: nausea
|
3 Number of Adverse Events
|
3 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: odynophagia
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: reflux gastritis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: vomiting
|
4 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
General disorders and administration site conditions: fatigue
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
General disorders and administration site conditions: medical device site reaction
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
General disorders and administration site conditions: pain
|
3 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
General disorders and administration site conditions: polyp
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
General disorders and administration site conditions: pyrexia
|
3 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: Clostridium difficile colitis
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: Clostridium difficile infection
|
2 Number of Adverse Events
|
3 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: COVID-19
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: cystitis
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: Escherichia urinary tract infection
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: gastroenteritis
|
3 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: influenza
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: oral candidiasis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: perineal abscess
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: respiratory tract infection
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: urinary tract infection
|
3 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Injury, poisoning and procedural complications: fall
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Injury, poisoning and procedural complications: spinal fracture
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Injury, poisoning and procedural complications: synovial rupture
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: blood creatinine increased
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: cardiac murmur
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: Clostridium test positive
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: C-reactive protein increased
|
13 Number of Adverse Events
|
7 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: international normalised ratio increased
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Investigations: white blood cell count increased
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Metabolism and nutrition disorders: folate deficiency
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Metabolism and nutrition disorders: hypokalaemia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Metabolism and nutrition disorders: hyponatraemia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Metabolism and nutrition disorders: vitamin B12 deficiency
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Metabolism and nutrition disorders: vitamin D deficiency
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Musculoskeletal and connective tissue disorders: back pain
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Musculoskeletal and connective tissue disorders: musculoskeletal chest pain
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Nervous system disorders: dizziness
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Renal and urinary disorders: oliguria
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Reproductive system and breast disorders: prostatitis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Respiratory, thoracic and mediastinal disorders: catarrh
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Skin and subcutaneous tissue disorders: angioedema
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Skin and subcutaneous tissue disorders: toxic skin eruption
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Blood and lymphatic system disorders: anaemia
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Blood and lymphatic system disorders: iron deficiency anaemia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Blood and lymphatic system disorders: leukocytosis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Cardiac disorders: cardiac failure
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Ear and labyrinth disorders: vertigo
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: abdominal pain upper
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: colitis ulcerative
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: constipation
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: dental discomfort
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: diarrhea
|
17 Number of Adverse Events
|
27 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: erosive duodenitis
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: flatulence
|
2 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Infections and infestations: pneumonia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Nervous system disorders: headache
|
3 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Nervous system disorders: migraine
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Psychiatric disorders: agitation
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Psychiatric disorders: insomnia
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Psychiatric disorders: mixed anxiety and depressive disorder
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Renal and urinary disorders: microalbuminuria
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Skin and subcutaneous tissue disorders: hidradenitis
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Skin and subcutaneous tissue disorders: pruritus
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Skin and subcutaneous tissue disorders: vascular purpura
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Surgical and medical procedures: prophylaxis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Surgical and medical procedures: tooth extraction
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Vascular disorders: hot flush
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Type of Adverse Events Per Ramdomisation Group
Vascular disorders: hypertensive crisis
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentNumber of Serious Adverse Events per ramdomisation group since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Number of Serious Adverse Events Per Ramdomisation Group
|
11 Number of Serious Adverse Events
|
5 Number of Serious Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentType of Serious Adverse Events per ramdomisation group since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Type of Serious Adverse Events Per Ramdomisation Group
Cardiac disorders: cardiac failure
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: colitis ulcerative
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: diarrhea
|
0 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: inflammatory bowel disease
|
0 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: intra-abdominal fluid collection
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Gastrointestinal disorders: rectal haemorrhage
|
0 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: anal abscess
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: Clostridium difficile infection
|
1 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: necrotising fasciitis
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: pneumonia
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: pyelonephritis acute
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Infections and infestations: sepsis
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Neoplasms, benign, malignant and unspecified (incl cysts and polyps): renal cancer
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome
|
0 Number of Serious Adverse Events
|
1 Number of Serious Adverse Events
|
|
Type of Serious Adverse Events Per Ramdomisation Group
Respiratory, thoracic and mediastinal disorders: acute respiratory failure
|
1 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentAdverse Events related to the treatment since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Adverse Events Related to the Treatment
|
1 Number of Adverse Events
|
3 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentAdverse Event Seriousness since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Adverse Event Seriousness
Mild
|
70 Number of Adverse Events
|
77 Number of Adverse Events
|
|
Adverse Event Seriousness
Moderate
|
17 Number of Adverse Events
|
22 Number of Adverse Events
|
|
Adverse Event Seriousness
Severe
|
1 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Adverse Event Seriousness
Life threatening
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Adverse Event Seriousness
Death
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentAdverse Events related to the CDI since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Adverse Events Related to the CDI
Clostridium difficile colitis
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
|
Adverse Events Related to the CDI
Diarrhea
|
17 Number of Adverse Events
|
28 Number of Adverse Events
|
|
Adverse Events Related to the CDI
Clostridium difficile infection
|
3 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Adverse Events Related to the CDI
Positive Clostridium test
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
|
Adverse Events Related to the CDI
Total of Adverse Events related to the CDI
|
21 Number of Adverse Events
|
33 Number of Adverse Events
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentPercentage of patients that die due to CDI after a defined period of time from the beginning of the treatment.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Mortality Associated With CDI
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentPercentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Intensive Care Unit Admissions (ICU)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after the start of the treatmentAdverse Events of special interest since baseline.
Outcome measures
| Measure |
MBK-01
n=45 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Adverse Events of Special Interest
Prostatitis
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Perineal abscess
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Pain
|
3 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Nausea
|
3 Number of AEs
|
3 Number of AEs
|
|
Adverse Events of Special Interest
Migraine
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Headache
|
2 Number of AEs
|
3 Number of AEs
|
|
Adverse Events of Special Interest
Haemorrhoids
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Gastroenteritis
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Flatulence
|
1 Number of AEs
|
3 Number of AEs
|
|
Adverse Events of Special Interest
Fatigue
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Diarrhoea
|
17 Number of AEs
|
26 Number of AEs
|
|
Adverse Events of Special Interest
Cystitis
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Constipation
|
1 Number of AEs
|
2 Number of AEs
|
|
Adverse Events of Special Interest
Colitis ulcerative
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Clostridium test positive
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Clostridium difficile infection
|
3 Number of AEs
|
4 Number of AEs
|
|
Adverse Events of Special Interest
Clostridium difficile colitis
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Vomiting
|
4 Number of AEs
|
2 Number of AEs
|
|
Adverse Events of Special Interest
Urinary tract infection
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Pyrexia
|
3 Number of AEs
|
2 Number of AEs
|
|
Adverse Events of Special Interest
Irritable bowel syndrome
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Influenza
|
1 Number of AEs
|
0 Number of AEs
|
|
Adverse Events of Special Interest
Inflammatory bowel disease
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
COVID-19
|
0 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
C-reactive protein increased
|
13 Number of AEs
|
5 Number of AEs
|
|
Adverse Events of Special Interest
Abdominal pain upper
|
1 Number of AEs
|
1 Number of AEs
|
|
Adverse Events of Special Interest
Abdominal pain
|
4 Number of AEs
|
3 Number of AEs
|
|
Adverse Events of Special Interest
Abdominal discomfort
|
0 Number of AEs
|
2 Number of AEs
|
SECONDARY outcome
Timeframe: Day 0, 8 weeks and 6 months after the start of the treatmentPopulation: In addition to the lack of some data by different reasons through the study (i.e. dropout due to the use of forbidden medication), not all the patients completed all the visits.
For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
Outcome measures
| Measure |
MBK-01
n=42 Participants
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=46 Participants
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Mental health (day 0)
|
55.27 score on a scale
Standard Deviation 16.92
|
56.06 score on a scale
Standard Deviation 17.17
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Mental health (8 weeks)
|
60 score on a scale
Standard Deviation 16.42
|
57.83 score on a scale
Standard Deviation 13.84
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Mental health (6 months)
|
63.69 score on a scale
Standard Deviation 11.97
|
62.34 score on a scale
Standard Deviation 12.81
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Function (day 0)
|
56.9 score on a scale
Standard Deviation 35.9
|
57.07 score on a scale
Standard Deviation 33.71
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Function (8 weeks)
|
68.5 score on a scale
Standard Deviation 30.6
|
62.58 score on a scale
Standard Deviation 30.44
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Function (6 months)
|
77.5 score on a scale
Standard Deviation 27.01
|
77.73 score on a scale
Standard Deviation 27.14
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Bodily pain (day 0)
|
52.91 score on a scale
Standard Deviation 29.84
|
57.25 score on a scale
Standard Deviation 29.07
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Bodily pain (8 weeks)
|
35.19 score on a scale
Standard Deviation 29.19
|
40.5 score on a scale
Standard Deviation 28.33
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Bodily pain (6 months)
|
35.19 score on a scale
Standard Deviation 33.78
|
27.27 score on a scale
Standard Deviation 28.27
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
General health (day 0)
|
55.13 score on a scale
Standard Deviation 17.07
|
54.85 score on a scale
Standard Deviation 20.62
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
General health (8 weeks)
|
47.18 score on a scale
Standard Deviation 18.04
|
49.13 score on a scale
Standard Deviation 17.5
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
General health (6 months)
|
41.03 score on a scale
Standard Deviation 15.5
|
38.46 score on a scale
Standard Deviation 16.14
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Vitality (day 0)
|
38.1 score on a scale
Standard Deviation 11.52
|
35.69 score on a scale
Standard Deviation 18.56
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Vitality (8 weeks)
|
36.39 score on a scale
Standard Deviation 17.02
|
40.86 score on a scale
Standard Deviation 11.85
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Vitality (6 months)
|
35.42 score on a scale
Standard Deviation 7.22
|
36.36 score on a scale
Standard Deviation 8.56
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Social role (day 0)
|
65.08 score on a scale
Standard Deviation 15.53
|
63.77 score on a scale
Standard Deviation 19.02
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Social role (8 weeks)
|
63.33 score on a scale
Standard Deviation 14.78
|
63.44 score on a scale
Standard Deviation 11.72
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Social role (6 months)
|
59.72 score on a scale
Standard Deviation 11.14
|
69.7 score on a scale
Standard Deviation 10.05
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Emotional role (day 0)
|
59.13 score on a scale
Standard Deviation 39.04
|
68.3 score on a scale
Standard Deviation 32.18
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Emotional role (8 weeks)
|
82.78 score on a scale
Standard Deviation 25.7
|
70.43 score on a scale
Standard Deviation 28.04
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Emotional role (6 months)
|
86.11 score on a scale
Standard Deviation 22.29
|
84.09 score on a scale
Standard Deviation 20.57
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Role (day 0)
|
33.48 score on a scale
Standard Deviation 33.44
|
36.55 score on a scale
Standard Deviation 32.81
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Role (8 weeks)
|
69.17 score on a scale
Standard Deviation 35.84
|
57.46 score on a scale
Standard Deviation 30.64
|
|
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
Physical Role (6 months)
|
72.92 score on a scale
Standard Deviation 29.95
|
74.43 score on a scale
Standard Deviation 34.51
|
Adverse Events
MBK-01
Serious events: 9 serious events
Other events: 36 other events
Deaths: 1 deaths
Fidaxomicin
Serious events: 4 serious events
Other events: 38 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MBK-01
n=45 participants at risk
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 participants at risk
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Anal abscess
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Clostridium difficile infection
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Necrotising fasciitis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Pyelonephritis acute
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Sepsis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
Other adverse events
| Measure |
MBK-01
n=45 participants at risk
Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
|
Fidaxomicin
n=47 participants at risk
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
8.9%
4/45 • Number of events 4 • Up to 6 months after the start of the treatment
|
6.4%
3/47 • Number of events 3 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Dental discomfort
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Diarrhea
|
35.6%
16/45 • Number of events 17 • Up to 6 months after the start of the treatment
|
46.8%
22/47 • Number of events 27 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Flatulence
|
4.4%
2/45 • Number of events 2 • Up to 6 months after the start of the treatment
|
8.5%
4/47 • Number of events 4 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.4%
2/45 • Number of events 2 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 3 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Odynophagia
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Reflux gastritis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
3/45 • Number of events 4 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
General disorders
Fatigue
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
General disorders
Medical device site reaction
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
General disorders
Pain
|
4.4%
2/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
General disorders
Polyp
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
General disorders
Pyrexia
|
4.4%
2/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Clostridium difficile infection
|
4.4%
2/45 • Number of events 2 • Up to 6 months after the start of the treatment
|
6.4%
3/47 • Number of events 3 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
COVID-19
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Cystitis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Gastroenteritis
|
4.4%
2/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Influenza
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Oral candidiasis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Perineal abscess
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Infections and infestations
Urinary tract infection
|
6.7%
3/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Investigations
Cardiac murmur
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Investigations
Clostridium test positive
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Investigations
C-reactive protein increased
|
24.4%
11/45 • Number of events 13 • Up to 6 months after the start of the treatment
|
12.8%
6/47 • Number of events 7 • Up to 6 months after the start of the treatment
|
|
Investigations
International normalised ratio increased
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Investigations
White blood cell count increased
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
4.3%
2/47 • Number of events 2 • Up to 6 months after the start of the treatment
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 3 • Up to 6 months after the start of the treatment
|
8.5%
4/47 • Number of events 4 • Up to 6 months after the start of the treatment
|
|
Nervous system disorders
Migraine
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Renal and urinary disorders
Oliguria
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Reproductive system and breast disorders
Prostatitis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Surgical and medical procedures
Prophylaxis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Vascular disorders
Hot flush
|
0.00%
0/45 • Up to 6 months after the start of the treatment
|
2.1%
1/47 • Number of events 1 • Up to 6 months after the start of the treatment
|
|
Vascular disorders
Hypertensive crisis
|
2.2%
1/45 • Number of events 1 • Up to 6 months after the start of the treatment
|
0.00%
0/47 • Up to 6 months after the start of the treatment
|
Additional Information
Olaia Aurtenetxe Saez
Mikrobiomik Healthcare Company S.L.
Phone: +34 944 540 166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If the results are not submitted by the sponsor, the PI may publish them in scientific journals, provided that they mention the sponsor, at least, within the first year after the authorization and marketing in any country (for non-commercialized products). The sponsor must receive for review a copy of the text, except otherwise agreed, at least 45 days before the submission (20 days before for Abstracts). The PI may only use these data with prior express written authorization from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER