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Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

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

• Information and consent of parents and the patient

• 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.

• 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.

⁃ \- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis.

Locations
Other Locations
France
Hôpital Necker-Enfants Malades
RECRUITING
Paris
Contact Information
Primary
Bénédicte Pigneur, MD
benedicte.pigneur@aphp.fr
1 44 49 25 16
Backup
Hélène Morel
helene.morel@aphp.fr
1 71 19 63 46
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2029-06
Participants
Target number of participants: 80
Treatments
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.
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.
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.
Sponsors
Collaborators: URC-CIC Paris Descartes Necker Cochin
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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