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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06228352
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jan 29, 2024
Start date
Jun 9, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Ulcerative colitis flare-up
    Patient with ulcerative colitis, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months, presenting with a flare of UC defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score between 35 and 65.
  • Arm: Ulcerative colitis remission
    Patient with ulcerative colitis, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months and in clinical remission defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score under 10.
  • Arm: Controls
    Paediatric patients (\<18 years) without chronic liver disease or chronic digestive disease (celiac disease, inflammatory bowel disease, chronic diarrhea) and hospitalized for an endoscopic examination to investigate abdominal pain, gastroesophageal reflux or polyposis.

Primary Outcome Measure

Composition of bile acids [ Time Frame: Day 0 ]

Central Contacts

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