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Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis - Trial NCT06228352

Access comprehensive clinical trial information for NCT06228352 through Pure Global AI's free database. This phase not specified trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 80 participants.

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NCT06228352
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Trial Details
ClinicalTrials.govNCT06228352
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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

Study Focus

Ulcerative Colitis

Feces collection

Observational

other

Sponsor & Location

Assistance Publique - Hôpitaux de Paris

Paris, France

Timeline & Enrollment

N/A

Mar 01, 2024

Mar 01, 2027

80 participants

Primary Outcome

Composition of bile acids

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.

ICD-10 Classifications

Ulcerative colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06228352

Non-Device Trial