Poop pills could help kids with colitis stay healthy
NCT ID NCT05202990
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether frozen stool capsules (fecal transplants) can help children aged 8-17 with ulcerative colitis stay in remission after steroid treatment. Participants will receive either capsules or enemas containing healthy donor stool. The main goal is to see if the capsules increase gut bacteria diversity at 6 months.
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 transplantation (FMT) via frozen stool capsules
- What this could lead to
- If successful, this could offer a less invasive way to maintain remission in children with ulcerative colitis by restoring healthy gut bacteria.
- What could go wrong
- This is a small early-phase trial with only 26 participants, so results may not apply broadly. The treatment involves colonoscopy and swallowing many capsules, which some children may find difficult.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 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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8 to 17 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 for patients: * Patient aged 8 to 17 years old * Ulcerative colitis (UC), whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria * Moderate active UC defined by a PUCAI score \> 35 and responding to corticosteroid treatment with a PUCAI score \<10 at enrollment * Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months * Patient able to swallow test capsules * For girls of childbearing age: * To have a negative blood (or urine) pregnancy test * To agree to use a reliable contraceptive method from visit 1 until the end of the research * Patient with health insurance * Informed written consent form signed by both parents or by the person (s) with parental authority Exclusion Criteria for patients: * isolated proctitis (\<5 cm) * Being on enteral nutrition * Have received antibiotic or antifungal treatment in the 4 weeks prior to enrollment * Having a Clostridioides difficile infection in the 4 weeks prior to enrollment; * Being pregnant or breastfeeding, or have a positive pregnancy test; * Have a contraindication to colonoscopy or general anaesthesia
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital
Paris, 75015, France
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Department of Pediatric Gastroenterology, Robert Debré Hospital
Paris, 75019, France
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Department of gastroenterology, Armand Trousseau Hospital
Paris, 75012, France