NCT07172945Not yet recruiting
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options. The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression. Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 4500 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- Sept 2025
- Primary completion date
- Nov 2040
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07172945
What you commit to
- Study type: Interventional
- Planned participants: 4500
- From Sept 2025 to the primary completion date, Nov 2040
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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).
Other illness
- Subject suffering from a chronic disease
Other
- For all patients and control subjects
- Subjects under guardianship, curatorship or safeguard of justice.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.