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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Qualifiers

Pediatric patients (<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.

Information and consent of parents and the patient

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Feces collection

Treatment groups

80 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator