Informations générales (source: ClinicalTrials.gov)
Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis. (T-FORE)
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2025
octobre 2027
18 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Julie LEMALE, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Bénédicte PIGNEUR | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Department of Pediatric Gastroenterology, Robert Debré Hospital - 75019 - Paris - France | Alexis MOSCA, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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