Preventing recurrent pouchitis after fecal microbiota transplant in ulcerative colitis patients

Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

This study is testing if a fecal microbiota transplant can help adults with ulcerative colitis who have had repeated pouchitis episodes avoid getting pouchitis again.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 13 sites (Angers and 12 other locations)
• Trial ID: NCT03524352 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of fecal microbiota transplant (FMT) in preventing recurrent pouchitis in patients who have undergone ileal pouch-anal anastomosis (IPAA) due to ulcerative colitis. The study aims to enroll adults who have experienced recurrent pouchitis, defined as multiple episodes within the past year. Participants will be randomly assigned to receive either FMT or a placebo, and their pouchitis symptoms will be monitored over time to assess the treatment's efficacy. The trial is designed to provide insights into the potential benefits of FMT as a therapeutic option for managing this common complication.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone IPAA and have a history of recurrent pouchitis.

Not a fit: Patients who have not experienced recurrent pouchitis or those with severe pouchitis symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of recurrent pouchitis, improving the quality of life for patients with ulcerative colitis.

How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplant for various gastrointestinal conditions, suggesting potential success for this approach in pouchitis.

Eligibility criteria

4.2. INCLUSION CRITERIA

Subjects must satisfy the following criteria to be enrolled in the study:

1. Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure.
3. Willing and able to adhere to the study visit scheduled and other protocol requirements.
4. Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
5. Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
6. Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) \< 7 at the screening
7. Subject must affiliation with social security system or beneficiary from such system
8. Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception

4.3. NON-INCLUSION CRITERIA

Subjects who meet any of the following non inclusion criteria could not be enrolled in this study:

1. Crohn disease or indeterminate colitis
2. Anastomotic stenosis
3. Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
4. Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
5. Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose.
6. Prior treatment with a biologic within 3 month prior the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose.
7. Documented active infection of any kind in the last 6 months likely to require anti-infective treatment during the next months
8. Absolute neutrophil count (ANC) \< 1.5 x 109 /L (1,500 mm3)
9. Infection with chronic HIV
10. Pregnant female or breastfeeding
11. Chronic medical or psychiatric disease that may interfere with subject's ability to comply with study procedures
12. Administration of investigational drug within 3 months prior to planned FMT
13. Adults under guardianship, Safeguard justice or trusteeship
14. Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
15. Patients with contraindication to colonoscopy or anesthesia (if necessary)

Where this trial is running

Angers and 12 other locations

• CHU Angers — Angers, France (Not_yet_recruiting)
• CHU Estaing — Clermont-Ferrand, France (Recruiting)
• Hopital Beaujon, Clichy — Clichy, France (Recruiting)
• CHU Henry Mondor — Créteil, France (Recruiting)
• CHU Claude Huriez — Lille, France (Recruiting)
• CHU Lyon Sud — Lyon, France (Recruiting)
• CHRU Nancy — Nancy, France (Recruiting)
• CHU of Nantes — Nantes, France (Recruiting)
• CHU de l'Archet 2 — Nice, France (Recruiting)
• Hopital Saint Antoine — Paris, France (Recruiting)
• Groupe Hospitalier Sud- Hopital Haut-lévêque — Pessac, France (Recruiting)
• CHU Pontchaillou — Rennes, France (Recruiting)
• CHU Toulouse — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Trang POISSON

Conditions Pouchitis; recurrent pouchitis; fecal microbiota transplant