the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
NCT ID: NCT03524352
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
42 participants
INTERVENTIONAL
2020-03-12
2028-05-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fecal microbiota
fecal microbiota
fecal microbiota in suspension
placebo
Placebo
sterile saline
Interventions
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fecal microbiota
fecal microbiota in suspension
Placebo
sterile saline
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Angers
Angers, , France
CHU Estaing
Clermont-Ferrand, , France
Hopital Beaujon, Clichy
Clichy, , France
CHU Henry Mondor
Créteil, , France
CHU Claude Huriez
Lille, , France
CHU Lyon Sud
Lyon, , France
CHRU Nancy
Nancy, , France
CHU of Nantes
Nantes, , France
CHU de l'Archet 2
Nice, , France
Hopital Saint Antoine
Paris, , France
Groupe Hospitalier Sud- Hopital Haut-lévêque
Pessac, , France
CHU Pontchaillou
Rennes, , France
CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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DIB
Role: primary
BUISSON
Role: primary
BOUHNIK
Role: primary
UZZAN
Role: primary
NACHURY
Role: primary
NANCEY
Role: primary
Caron
Role: primary
HEBUTERNE
Role: primary
Sokol
Role: primary
LAHARIE
Role: primary
BOUGUEN
Role: primary
ALRIC
Role: primary
References
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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.
Other Identifiers
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RC17_0021
Identifier Type: -
Identifier Source: org_study_id
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