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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vancomycin

Criteria

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)

• Clinical response to 4-10 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' capsule is administered

• Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT

• Active, Severe Gastroparesis

• Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are not prohibited

• Neutropenia, ≤ 500 neutrophils/ml [noted in medical records and resulted within 7 days of Visit 1])

• Symptomatic co-infection with another intestinal pathogen as determined by chart review

• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for any active malignancy. Patients on maintenance chemotherapy could be enrolled after consultation with the study Medical Monitor

• Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions

• Expected life expectancy is less than 6 months

• Use of investigational drugs, biologics, or devices within 30 days prior to randomization.

• Women who are pregnant, lactating or planning on becoming pregnant during the study

• Not suitable for study participation due to other reasons at the discretion of the investigators