Status:
NOT_YET_RECRUITING
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Sorbonne University
Conditions:
Crohn
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditional...
Detailed Description
Inflammatory Bowel Diseases (IBD) are chronic, disabling conditions that affect young adults with a predilection for flare-ups interspersed with periods of remission. Crohn's disease (CD) and ulcerati...
Eligibility Criteria
Inclusion
- For all patients and control subjects
- Person able to give free and informed consent.
- Age ≥ 18 years.
- Beneficiary of a social protection scheme or entitled person (excluding AME).
- Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital
- Patients with IBD :
- \- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital.
- Microbiota control' subjects:
- \- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT.
- Endoscopy control' subjects:
- \- Subjects with a medical indication for digestive endoscopy with biopsies:
- For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis
- For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer.
Exclusion
- For all patients and control subjects
- Subjects under guardianship, curatorship or safeguard of justice.
- Subjects who do not speak French.
- IBD patients:
- \- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
- Endoscopy control' and "microbiota control" subjects:
- Subject suffering from a chronic disease
- Antibiotics taken in the 6 weeks prior to endoscopy
- Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2040
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT07172945
Start Date
September 1 2025
End Date
November 1 2040
Last Update
September 15 2025
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