NCT06228352Recruiting
Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 18 Jan 2024
- Start date
- Jun 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Ulcerative colitis
- NCT number
- NCT06228352
What you commit to
- Study type: Observational
- Planned participants: 80
- From Jun 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion.
Other
- 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
Who the study is looking for
- Pediatric patients (\<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.
- Information and consent of parents and the patient
- 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
- 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
- \- 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).
Criteria the registry did not label
- For everyone :
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.