Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients (NCT03617445) | Clinical Trial Compass
TerminatedPhase 2
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
Stopped: Study drug not available due to COVID-19 FDA restrictions
United States3 participantsStarted 2022-08-03
Plain-language summary
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Is willing to provide written informed consent.
* Is willing to comply with all study procedures and be available for the duration of the study.
* Can take oral medication
* At least 18 years of age.
* Is a solid organ transplant (SOT) recipient
* Has had at recurrent C. difficile infection defined as: positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 180 day period following completion of treatment for prior episode
* History of positive IgG test to cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) for subject or donor
* Clinical response to 4-14 days of oral antibiotic standard of care treatment for the current episode of CDI. Clinical response is defined as greater than or equal to 25% reduction of diarrhea.
* Negative urine or serum pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment
Exclusion Criteria:
* Major bowel resection surgery within 90 days of randomization
* Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
* History of total colectomy or bariatric surgery
* Known or suspected toxic megacolon and/or small bowel ileus
* Presence of colostomy or ileostomy.
* Taking concomitant antibiotics within 48 hours of Visit 2. Topical antibiotics, and antibiotics for transplant prophylaxis are permitted
* Dysphagia; oropharyngeal, S), or patient has evidence of dysphagia when the 'safety test' capsul…
What they're measuring
1
Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin