💬In plain words
What the trial is, and whether it could suit you
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 abnormaliti
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 disease.
Group 3: Healthy control subjects
Inclusion criteria:
\- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis.
Non-inclusion criteria:
* Patient with chronic liver disease.
* Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).
Hôpital Necker-Enfants Malades
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky