the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

NCT03524352 | Active Not Recruiting Phase 3

• 1 other identifier: RC17_0021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 13

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available. Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.

Conditions

Pouchitis

Keywords

recurrent pouchitis; fecal microbiota transplant

Outcome Measures

Primary Outcomes (1)

• Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)

  106 weeks

Secondary Outcomes (10)

• Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)

  24 weeks

• Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter)

  52 weeks

• Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment

  52 weeks

• Number of adverse events

  104 weeks

• Number of fecal microbiota engraftment by 16S sequencing

  8 weeks

Study Arms (2)

fecal microbiota

EXPERIMENTAL

Other: fecal microbiota

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

fecal microbiota OTHER

fecal microbiota in suspension

fecal microbiota

Placebo OTHER

sterile saline

placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure.
• Willing and able to adhere to the study visit scheduled and other protocol requirements.
• Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
• 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).
• Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) \< 7 at the screening
• Subject must affiliation with social security system or beneficiary from such system
• Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception
• Crohn disease or indeterminate colitis
• Anastomotic stenosis
• Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
• Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
• 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.
• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (13)

CHU Angers

Angers, France

Location

CHU Estaing

Clermont-Ferrand, France

Location

Hopital Beaujon, Clichy

Clichy, France

Location

CHU Henry Mondor

Créteil, France

Location

CHU Claude Huriez

Lille, France

Location

CHU Lyon Sud

Lyon, France

Location

CHRU Nancy

Nancy, France

Location

CHU of Nantes

Nantes, France

Location

CHU de l'Archet 2

Nice, France

Location

Hopital Saint Antoine

Paris, France

Location

Groupe Hospitalier Sud- Hopital Haut-lévêque

Pessac, France

Location

CHU Pontchaillou

Rennes, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

• Trang-Poisson C, Kerdreux E, Poinas A, Planche L, Sokol H, Bemer P, Cabanas K, Hivernaud E, Biron L, Flet L, Montassier E, Le Garcasson G, Chiffoleau A, Jobert A, Lepelletier D, Caillon J, Le Pape P, Imbert BM, Bourreille A. Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2020 Jun 3;21(1):455. doi: 10.1186/s13063-020-04330-1.

  PMID: 32493442 DERIVED

MeSH Terms

Conditions

Pouchitis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: March 12, 2020
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): May 12, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (13)