Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis (NCT06228352) | Clinical Trial Compass
RecruitingNot Applicable
Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
France80 participantsStarted 2026-06-09
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.