Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
Phase 2 · Testing Fecal Microbiota Transplantation by Stool capsules and Fecal Microbiota Transplantation… · 3 sites · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation by Stool capsules (a drug) and Fecal Microbiota Transplantation by Intra-rectal enemas (a drug) as a possible treatment. Condition(s) listed: Pediatric Ulcerative Colitis in Remission.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 8 to 17
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 7 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 26 participants are expected to take part.
- Start date: 2026-07-01 (planned).
- Main results expected around 2028-07-01 (estimate from the record).
- 3 study sites listed in France.
Main thing being measured
- Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months. (6 months after the first Fecal Microbiota Transplantation (FMT))
In the researchers’ words
The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Pediatric Ulcerative Colitis in Remission |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | MRSU 938 - Research Center of Saint Antoine; URC-CIC Paris Descartes Necker Cochin |
| Enrollment | 26 (estimated) |
| Start date | 2026-07-01 |
| Primary completion (est.) | 2028-07-01 |
| First posted | 2022-01-24 |
| Last updated | 2026-05-06 |
| Official title | Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis. |
| ClinicalTrials.gov ID | NCT05202990 |
Interventions
- Fecal Microbiota Transplantation by Stool capsules (Drug)
After colon cleansing using PolyEthylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive orally FMT (frozen stools capsules prepared from healthy donor feces). - Fecal Microbiota Transplantation by Intra-rectal enemas (Drug)
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive first FMT (frozen preparation of stools) by infusion in caecum during colonoscopy and the second and third doses by enemas.
Full eligibility criteria (from the record)
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
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of gastroenterology, Armand Trousseau Hospital | Paris | France | |
| Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital | Paris | France | |
| Department of Pediatric Gastroenterology, Robert Debré Hospital | Paris | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.