Trial Outcomes & Findings for FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI (NCT NCT02255305)
NCT ID: NCT02255305
Last Updated: 2023-03-03
Results Overview
Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
90 days
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
FMT Group (Intervention Arm)
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Baseline characteristics by cohort
| Measure |
FMT Group (Intervention Arm)
n=2 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=4 Participants
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
89.5 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
79.75 years
STANDARD_DEVIATION 24.9 • n=107 Participants
|
83 years
STANDARD_DEVIATION 21.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
United States
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: One patient in the control arm was lost to follow-up before the 30-day check in period
Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis
Outcome measures
| Measure |
FMT Group (Intervention Arm)
n=2 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=3 Participants
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Number of Patients With Clinical Resolution of Diarrhea
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Unable to calculate time to clinical resolution as patients did not experience clinical resolution or lost to follow-up
Amount of time it takes for patient to have cessation of diarrhea and abdominal pain/gastrointestinal symptoms (or return to baseline) and normalization of white blood cell count, creatinine, and temperature.
Outcome measures
| Measure |
FMT Group (Intervention Arm)
n=1 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Time to Clinical Resolution of Symptoms
|
44 days
|
—
|
SECONDARY outcome
Timeframe: 90 daysPatients' length of stay post-procedure will be measured
Outcome measures
| Measure |
FMT Group (Intervention Arm)
n=2 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=4 Participants
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Hospital Length of Stay
|
22 days
Standard Deviation 18.4
|
6.5 days
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 90 daysPopulation: One patient in the control arm was lost to follow-up before the 30-day check in period
Number of patients re-admitted to the hospital for recurrent Clostridium difficile infection
Outcome measures
| Measure |
FMT Group (Intervention Arm)
n=2 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=3 Participants
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Number of Patients With Hospital Readmission
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: One patient in the control arm was lost to follow-up before the 30-day check in period
Number of patients who died from any cause within 90 days of randomization
Outcome measures
| Measure |
FMT Group (Intervention Arm)
n=2 Participants
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=3 Participants
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
FMT Group (Intervention Arm)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Antimicrobial Group (Control Arm)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FMT Group (Intervention Arm)
n=2 participants at risk
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
FMT: Patients in the FMT group will receive \~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
|
Antimicrobial Group (Control Arm)
n=4 participants at risk
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Antimicrobials: Patients randomized to the control group will receive antimicrobials targeting C. difficile.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 6 • 6 months
|
|
General disorders
Fever
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 17 • 6 months
|
100.0%
4/4 • Number of events 17 • 6 months
|
|
General disorders
Fatigue/Malaise
|
100.0%
2/2 • Number of events 18 • 6 months
|
100.0%
4/4 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 3 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal distention or bloating
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • 6 months
|
75.0%
3/4 • Number of events 7 • 6 months
|
|
General disorders
Dehydration
|
50.0%
1/2 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Colitis Symptoms
|
0.00%
0/2 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Weight Loss
|
0.00%
0/2 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Dysphagia
|
0.00%
0/2 • 6 months
|
0.00%
0/4 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place