Trial Outcomes & Findings for Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection (NCT NCT02770326)
NCT ID: NCT02770326
Last Updated: 2025-04-08
Results Overview
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
2 weeks after the FMT
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Fecal Microbiota Transplantation (FMT)
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Fecal Microbiota Transplantation (FMT)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Fecal Microbiota Transplantation (FMT)
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Fecal Microbiota Transplantation (FMT)
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
Baseline characteristics by cohort
| Measure |
Fecal Microbiota Transplantation (FMT)
n=10 Participants
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Fecal Microbiota Transplantation (FMT)
|
|---|---|
|
Age, Continuous
|
67 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after the FMTSafety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
Outcome measures
| Measure |
Fecal Microbiota Transplantation (FMT)
n=10 Participants
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Fecal Microbiota Transplantation (FMT)
|
|---|---|
|
Number of Participants Evaluated for Infection During Treatment Intervention
|
10 Participants
|
Adverse Events
Fecal Microbiota Transplantation (FMT)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fecal Microbiota Transplantation (FMT)
n=10 participants at risk
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Fecal Microbiota Transplantation (FMT)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
10/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
10/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hyperglycemic
|
80.0%
8/10 • 2 weeks after the FMT
|
|
Investigations
Alkaline phosphatase increased
|
70.0%
7/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.0%
6/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
60.0%
6/10 • 2 weeks after the FMT
|
|
Investigations
Platelet count decreased
|
60.0%
6/10 • 2 weeks after the FMT
|
|
Investigations
White blood cell count
|
60.0%
6/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
5/10 • 2 weeks after the FMT
|
|
Investigations
Lymphocyte count decreased
|
50.0%
5/10 • 2 weeks after the FMT
|
|
Investigations
Neutrophil count decreased
|
50.0%
5/10 • 2 weeks after the FMT
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • 2 weeks after the FMT
|
|
Investigations
Activated partial thromboplastin time prolonged
|
30.0%
3/10 • 2 weeks after the FMT
|
|
Investigations
INR increased
|
30.0%
3/10 • 2 weeks after the FMT
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • 2 weeks after the FMT
|
|
Investigations
Creatinine increased
|
20.0%
2/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
2/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
1/10 • 2 weeks after the FMT
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • 2 weeks after the FMT
|
Additional Information
Dr. Robin Mendelsohn, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place