Trial Outcomes & Findings for Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients (NCT NCT03617445)

Last Updated: 2025-01-09

Results Overview

Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

60 consecutive days

Results posted on

2025-01-09

Participant Flow

medical clinic

consent

Participant milestones

Participant milestones
Measure	FMT Oral Capsules/ Oral Vancomycin Placebo FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.	Placebo FMT Capsules/ Active Oral Vancomycin Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules
Overall Study STARTED	0	3
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FMT Oral Capsules/ Oral Vancomycin Placebo FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.	Placebo FMT Capsules/ Active Oral Vancomycin n=3 Participants Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules	Total n=3 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	3 Participants n=107 Participants	3 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 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	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	3 Participants n=107 Participants	3 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

PRIMARY outcome

Timeframe: 60 consecutive days

Population: Target enrollment was not met and data cannot be compared as all enrolled subjects were randomized to 1 arm only.

Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period)

Outcome measures

Outcome measures
Measure	FMT Oral Capsules/ Oral Vancomycin Placebo FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.	Placebo FMT Capsules/ Active Oral Vancomycin n=3 Participants Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules
Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 4, 29 weeks

Population: Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report.

Cdiff32 32-item questionnaire, with a range of 0 to 100, with 100 representing the best score, and 0 representing the worst score. Dietary component of the questionnaire linked to any stool microbiome data to determine whether diet influences gut microbiota.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 30 weeks of study participation

Population: Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report.

Using multiple metric of microbiota structure and function, analyze gut microbiome samples to evaluate the association between change in gut microbiome and recurrent CDI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up 30 weeks of study participation

Population: Target enrollment was not reached and all subjects were randomized to 1 arm only, so planned analyses cannot be performed.

List and evaluate all short- and medium-term safety events as defined in the study protocol for the safety of FMT in SOT patients

Outcome measures

Outcome measures
Measure	FMT Oral Capsules/ Oral Vancomycin Placebo FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.	Placebo FMT Capsules/ Active Oral Vancomycin n=3 Participants Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules
Number of Patients Who Experienced Short or Medium Term Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 30 weeks of study participation

Population: Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report.

Analysis all stool samples and compare the effects of FMT and oral vancomycin on intestinal colonization with multi-drug resistant organisms (other than C. difficile) in SOT patients

Outcome measures

Outcome data not reported

Adverse Events

FMT Oral Capsules/ Oral Vancomycin Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo FMT Capsules/ Active Oral Vancomycin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FMT Oral Capsules/ Oral Vancomycin Placebo FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.	Placebo FMT Capsules/ Active Oral Vancomycin n=3 participants at risk Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules
Metabolism and nutrition disorders Hospitalization due to toe infection	— 0/0 • 30 weeks No differences from standard definition of adverse events. Adverse events are inquired upon during weekly visits and follow-up phone visits by study staff.	33.3% 1/3 • Number of events 1 • 30 weeks No differences from standard definition of adverse events. Adverse events are inquired upon during weekly visits and follow-up phone visits by study staff.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nasia Safdar

University of Wisconsin-Madison

Phone: 608-263-1545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place