NCT06228352 Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
| NCT ID | NCT06228352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Ulcerative Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-06-09 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection. The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.
Eligibility Criteria
For everyone : Inclusion Criteria: * Pediatric patients (\<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital. * Information and consent of parents and the patient Exclusion Criteria: * Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion. * Patients colonized by C. difficile. * Pregnant or breastfeeding young girl. * Refusal of the protocol by parents or patient. For group 1: Patients with active UC Inclusion criteria: * Patient with UC, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria. * UC in flare defined by a PUCAI score of between 35 and 65. Non-inclusion criteria: * Patient with IBD unclassified or Crohn's disease. * Patient with isolated proctitis (\<5 cm). * Colectomized patients. * Patients with sclerosing cholangitis associated with their UC or liver disease. Group 2: Patients in UC remission Inclusion criteria: * Patient with UC, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria. * UC in remission defined by a PUCAI score \<10. Non-inclusion criteria: * Patient with IBD unclassified or Crohn's disease. * Patient with isolated proctitis (\<5 cm). * Colectomized patients. * Patients with sclerosing cholangitis associated with their UC or liver disease. Group 3: Healthy control subjects Inclusion criteria: \- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis. Non-inclusion criteria: * Patient with chronic liver disease. * Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).
Contact & Investigator
Bénédicte Pigneur, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06228352 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06228352 currently recruiting?
Yes, NCT06228352 is actively recruiting participants. Contact the research team at benedicte.pigneur@aphp.fr for enrollment information.
Where is the NCT06228352 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06228352 clinical trial?
NCT06228352 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Bénédicte Pigneur, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 80 participants.
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