UCRecruiting
Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
Observational · No treatment assigned · 1 site · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Up to age 17
- Any sex
Some of the main requirements, copied from the record:
- For everyone :
- Pediatric patients (<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.
- Information and consent of parents and the patient
Plus 20 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2026-06-09.
- Main results expected around 2029-06 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Composition of bile acids (Day 0)
In the researchers’ words
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).
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | URC-CIC Paris Descartes Necker Cochin |
| Enrollment | 80 (estimated) |
| Start date | 2026-06-09 |
| Primary completion (est.) | 2029-06 |
| First posted | 2024-01-29 |
| Last updated | 2026-06-24 |
| Official title | Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06228352 |
Interventions
- Feces collection (Other)
A single stool sample will be taken (a specific kit will be given to the patient for this) during a consultation for follow-up or hospitalization. Stool samples will be used to study the composition of the intestinal microbiota and to measure faecal biomarkers.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | France | Recruiting |
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.