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

Phase 3

Recruiting

• Conditions: Pouchitis
• Interventions: Other: fecal microbiota; Other: Placebo

• Registration Number: NCT03524352
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-14
• Study Start: 2020-03-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15
• Primary Completion: 2028-05-12
• Study Completion: 2028-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fecal microbiota	fecal microbiota	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)	52 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
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)	24 weeks

Trial Locations

Locations (12)

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Hopital Beaujon, Clichy; 🇫🇷 Clichy, France

CHU Angers; 🇫🇷 Angers, France

CHU Henry Mondor; 🇫🇷 Créteil, France

CHU Claude Huriez; 🇫🇷 Lille, France

CHU Lyon Sud; 🇫🇷 Lyon, France

CHU de l'Archet 2; 🇫🇷 Nice, France

CHU of Nantes; 🇫🇷 Nantes, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Groupe Hospitalier Sud- Hopital Haut-lévêque; 🇫🇷 Pessac, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CHU Toulouse; 🇫🇷 Toulouse, France