Poop pills may tame gut disease in major trial
NCT ID NCT03483246
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether transplanting healthy donor stool into the gut can help people with ulcerative colitis, a chronic bowel disease. About 150 adults with active or steroid-dependent disease will receive either real fecal transplants or a sham procedure. The goal is to see if this treatment can achieve remission without steroids, though ongoing management is still needed.
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 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Mar 2027
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 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Inclusion Criteria: Inclusion Criteria for patients : * Age ≥ 18 years and \< 75 years * Ulcerative colitis (according to the Lennard Jones criteria) diagnosed for at least 3 months and : * Currently active (PMC \> 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) Or * Currently treated by systemic corticosteroid (minimum 40 mg prednisone equivalent daily) within max 3 weeks Or * Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion) * Patient with health insurance (AME excepted) * Informed written consent * Female of child-bearing age with an active contraception and this during at least period of treatment until the end of active follow-up period (week 24) Inclusion Criteria for healthy volunteers donors : * Age ≥ 18 years and \< 50 years * 17 kg/m² \< body mass index \< 30 kg/m² * Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day * Subject with health insurance (AME excepted) * Informed Written consent Exclusion Criteria: Exclusion Criteria for patients : * UC complication requiring surgical treatment * Patient treated with high dose corticosteroid more than three weeks before inclusion (≥ 40 mg prednisone equivalent daily) except in case of steroid-dependence * Contraindication to colonoscopy or anesthesia * Pregnancy or breastfeeding during the study * Treatment preceding the colonoscopy with: * intravenous infliximab and/or vedolizumab and/or ustekinumab (\< 6 weeks before the planned date of the colonoscopy) and/or subcutaneous infliximab (\<2 weeks before the planned date of the colonoscopy), and /or adalimumab (\<2 weeks before the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (\<4 weeks before the planned date of the colonoscopy) * immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical immunosuppressant) started or stopped \< 3 months before the planned date of the colonoscopy * Antibiotics, antifungic or probiotics treatment \< 4 weeks before the planned date of the colonoscopy * participation in any other interventional study * patient under legal protection Exclusion Criteria for healthy volunteers donors : \- For details, please see protocol.
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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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Service de Gastroentérologie et Nutrition Hôpital Saint Antoine
Paris, Paris, 75012, France
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Other studies related to the condition(s) this trial covers.
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