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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the role of bile acids and gut bacteria in young people with Ulcerative Colitis (UC), particularly when they have a Clostridioides difficile infection (CDI). UC is a long-term condition that causes inflammation in the colon, and patients with UC are at a higher risk of getting CDI, which can lead to serious complications. Researchers want to understand how changes in bile acids and gut bacteria might contribute to this increased risk, especially during flare-ups of UC.

To participate in the trial, children under 18 years old who are being treated for UC at Necker-Enfants Malades Hospital may be eligible. They will need to have either an active flare of UC or be in remission. Healthy children undergoing endoscopic assessments may also be included as a comparison group. Participants will undergo tests to analyze their bile acids, gut bacteria, and other related substances. This research aims to improve our understanding of how these factors are connected, which could help develop better treatments for UC and CDI in the future.

Gender

ALL

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).