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NCT06228352Not yet recruiting

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
Assistance Publique - Hôpitaux de ParisClinicalTrials.govother
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
Feces collection
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Assistance Publique - Hôpitaux de Paris
Location
Paris, France
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2024
End date
Mar 01, 2027
Enrollment
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 colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06228352
Type
Non-Device Trial
About this record

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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