Poop pills may stop gut Flare-Ups after colitis surgery
NCT ID NCT03524352
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a fecal microbiota transplant (FMT) from a healthy donor can delay or prevent pouchitis, a common complication after ulcerative colitis patients have their colon removed and a pouch created. About 42 adults who have had this surgery and have had pouchitis before will receive either FMT or a placebo. Researchers will track how long it takes for pouchitis to return.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplant (FMT)
- What this could lead to
- If it works, this could provide a new way to prevent pouchitis flare-ups in people with ulcerative colitis who have had pouch surgery.
- What could go wrong
- This is a small, early-phase trial with only 42 participants, so results may not apply to everyone. FMT also carries risks like infection or digestive upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU Nancy
Nancy, France
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CHU Angers
Angers, France
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CHU Claude Huriez
Lille, France
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CHU Estaing
Clermont-Ferrand, France
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CHU Henry Mondor
Créteil, France
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CHU Lyon Sud
Lyon, France
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CHU Pontchaillou
Rennes, France
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CHU Toulouse
Toulouse, France
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CHU de l'Archet 2
Nice, France
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CHU of Nantes
Nantes, France
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Groupe Hospitalier Sud- Hopital Haut-lévêque
Pessac, France
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Hopital Beaujon, Clichy
Clichy, France
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Hopital Saint Antoine
Paris, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple topical treatment stop a common Post-Surgery complication in ulcerative colitis?
- Can a stool transplant soothe an inflamed pouch?
- Sound waves vs. scope: a gentler way to spot pouch inflammation?
- Can a stool transplant calm an inflamed pouch?
- Can a common antibiotic stop pouchitis from coming back?
- New combo tackles stubborn gut inflammation after colitis surgery