Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis

NCT06228352 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2026-06-09

Last updated

2026-06-24

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Feces collection

Feces collection: 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.

Study 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

Sex

ALL

Min age

—

Max age

17 Years

Healthy volunteers

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).

Primary outcome measure(s)

Composition of bile acids — Day 0
Description of the composition of primary and secondary bile acids. Fecal bile acids will be assayed by high performance liquid chromatography coupled with detection by tandem mass spectrometry and the quantification of each bile acid will be expressed as a percentage of total bile acids. The bile acid profile of the patients will be compared between the 3 groups: patients followed for ulcerative colitis (UC) in flare with or without a concomitant C difficile infection, patients with UC in clinical remission and healthy subjects without UC.

Trial sites (1)

Facility	City	Region	Status
Hôpital Necker-Enfants Malades	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06228352 on ClinicalTrials.gov ↗ ← All trials in France