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

NCT03617445 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: 2018-1056A534265SMPH/MEDICINE/INFECT DISProtocol Version 8/24/20221U01AI125053-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Clostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (1)

• Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin

  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)

  60 consecutive days

Secondary Outcomes (4)

• CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders

  Weeks 4, 29 weeks

• Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients

  up to 30 weeks of study participation

• Number of Patients Who Experienced Short or Medium Term Adverse Events

  Up 30 weeks of study participation

• Compare the Effects of FMT and Oral Vancomycin on Intestinal Colonization by Multi-drug-resistant Organisms Other Than C. Difficile in SOT Patients

  up to 30 weeks of study participation

Study Arms (2)

FMT oral capsules/ oral vancomycin placebo

ACTIVE COMPARATOR

FMT plus placebo vancomycin

Drug: FMT oral capsule; Drug: Oral Vancomycin placebo

Placebo FMT capsules/ Active oral vancomycin

ACTIVE COMPARATOR

Vancomycin plus FMT enema placebo

Drug: Oral Vancomycin; Drug: FMT oral placebo

Interventions

FMT oral capsule DRUG

FMT oral capsules, single dose of 5 capsules

Also known as: MTP-101-C

FMT oral capsules/ oral vancomycin placebo

Oral Vancomycin DRUG

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

Also known as: vancomycin

Placebo FMT capsules/ Active oral vancomycin

FMT oral placebo DRUG

Placebo oral capsules, single dose of 5 capsules

Also known as: Placebo MTP-101-C

Placebo FMT capsules/ Active oral vancomycin

Oral Vancomycin placebo DRUG

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.

Also known as: placebo

FMT oral capsules/ oral vancomycin placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Vancomycin

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Nasia Safdar
• Organization: University of Wisconsin-Madison

ns2@medicine.wisc.edu

608-263-1545

Study Officials

• Nasia Safdar, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase 2, double blind, doubly placebo-controlled, randomized trial assessing the treatment effects of FMT compared to oral Vancomycin for recurrent CDI in solid organ transplant recipients.

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 6, 2018
• Study Start: August 3, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)