Trial Outcomes & Findings for Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (NCT NCT03110133)
NCT ID: NCT03110133
Last Updated: 2022-10-05
Results Overview
Defined in the protocol as sustained clinical cure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
Week 8
Results posted on
2022-10-05
Participant Flow
Participant milestones
| Measure |
CP101
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Week 8
STARTED
|
106
|
100
|
|
Week 8
COMPLETED
|
101
|
96
|
|
Week 8
NOT COMPLETED
|
5
|
4
|
|
Week 24
STARTED
|
101
|
96
|
|
Week 24
COMPLETED
|
99
|
95
|
|
Week 24
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Baseline characteristics by cohort
| Measure |
CP101
n=102 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=96 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 17.26 • n=99 Participants
|
66.5 Years
STANDARD_DEVIATION 14.25 • n=107 Participants
|
66.2 Years
STANDARD_DEVIATION 15.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
North America
|
102 participants
n=99 Participants
|
96 participants
n=107 Participants
|
198 participants
n=206 Participants
|
|
Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months
1
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months
2
|
37 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months
3
|
46 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months
>3
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: mITT population
Defined in the protocol as sustained clinical cure
Outcome measures
| Measure |
CP101
n=102 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=96 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
|
76 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Safety population
Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)
Outcome measures
| Measure |
CP101
n=104 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=99 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Number of Participants With Occurrence of Treatment Emergent Adverse Events
|
96 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: mITT population
The number of days between IP administration and the first C. Difficile recurrence
Outcome measures
| Measure |
CP101
n=102 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=96 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Time to First Recurrent CDI Episode During the Study
|
17.1 Days
Standard Deviation 10.95
|
11.3 Days
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Week 24Defined in the protocol as sustained clinical cure
Outcome measures
| Measure |
CP101
n=102 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=96 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
|
75 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: Analysis population only included participants with a CDI recurrence up to week 8. Two of the recurrences in the primary efficacy analyses were imputed, therefore only 24 samples were available for this analysis.
NAP1 is the North American Pulse-field C. difficile subtype.
Outcome measures
| Measure |
CP101
n=24 Participants
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=37 Participants
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
Ribosomal NAP1/BI/027 Positive at Recurrence
|
6 Participants
|
7 Participants
|
|
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
Ribosomal NAP1/BI/027 Negative or Unknown at Recurrence
|
18 Participants
|
30 Participants
|
Adverse Events
CP101
Serious events: 16 serious events
Other events: 97 other events
Deaths: 1 deaths
Placebo
Serious events: 13 serious events
Other events: 92 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CP101
n=104 participants at risk
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=99 participants at risk
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
1.9%
2/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
2/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Cholecystitis infective
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Clostridium difficile infection
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Metapneumovirus infection
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Pleurisy viral
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Pyelonephritis
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Septic Shock
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Nervous system disorders
Dizziness
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Nervous system disorders
Syncope
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Cardiac failure congestive
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Arrhythmia
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Cardiomyopathy
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Cardiac disorders
Mitral valve incompetence
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Dysphagia
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Gastritis
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Nausea
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Injury, poisoning and procedural complications
Traumatic hematoma
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
2.0%
2/99 • 24 weeks
Based on Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Renal and urinary disorders
Renal hematoma
|
0.00%
0/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
|
Hepatobiliary disorders
Cholecystitis
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Product Issues
Device occlusion
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.96%
1/104 • 24 weeks
Based on Safety population
|
0.00%
0/99 • 24 weeks
Based on Safety population
|
Other adverse events
| Measure |
CP101
n=104 participants at risk
Full Spectrum Microbiota Capsule
Full Spectrum Microbiota: Orally administered donor derived microbiota
|
Placebo
n=99 participants at risk
Matching Placebo Capsule
Placebo: Placebo for CP101
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
54.8%
57/104 • 24 weeks
Based on Safety population
|
50.5%
50/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
34.6%
36/104 • 24 weeks
Based on Safety population
|
60.6%
60/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Defaecation urgency
|
32.7%
34/104 • 24 weeks
Based on Safety population
|
41.4%
41/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
26.0%
27/104 • 24 weeks
Based on Safety population
|
30.3%
30/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Nausea
|
26.9%
28/104 • 24 weeks
Based on Safety population
|
28.3%
28/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Abdominal tenderness
|
21.2%
22/104 • 24 weeks
Based on Safety population
|
31.3%
31/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Anal incontinence
|
18.3%
19/104 • 24 weeks
Based on Safety population
|
22.2%
22/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Haematochezia
|
10.6%
11/104 • 24 weeks
Based on Safety population
|
8.1%
8/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
6/104 • 24 weeks
Based on Safety population
|
8.1%
8/99 • 24 weeks
Based on Safety population
|
|
Gastrointestinal disorders
Constipation
|
7.7%
8/104 • 24 weeks
Based on Safety population
|
5.1%
5/99 • 24 weeks
Based on Safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.0%
25/104 • 24 weeks
Based on Safety population
|
36.4%
36/99 • 24 weeks
Based on Safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
11.5%
12/104 • 24 weeks
Based on Safety population
|
21.2%
21/99 • 24 weeks
Based on Safety population
|
|
Infections and infestations
Urinary tract infection
|
6.7%
7/104 • 24 weeks
Based on Safety population
|
7.1%
7/99 • 24 weeks
Based on Safety population
|
|
General disorders
Pyrexia
|
6.7%
7/104 • 24 weeks
Based on Safety population
|
11.1%
11/99 • 24 weeks
Based on Safety population
|
|
General disorders
Fatigue
|
8.7%
9/104 • 24 weeks
Based on Safety population
|
5.1%
5/99 • 24 weeks
Based on Safety population
|
|
Investigations
Pus in stool
|
5.8%
6/104 • 24 weeks
Based on Safety population
|
11.1%
11/99 • 24 weeks
Based on Safety population
|
|
Nervous system disorders
Headache
|
6.7%
7/104 • 24 weeks
Based on Safety population
|
1.0%
1/99 • 24 weeks
Based on Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restrictions on the PI are: (i) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to eighteen months from the lock-down of all study data and (ii) the sponsor can require the removal of its confidential information from results communications and may delay release for a period of up to 60 days for the purpose of filing patent applications.
- Publication restrictions are in place
Restriction type: OTHER