Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
Not applicable · Testing Blood, fecal, saliva and intestinal content samples and biopsies · Sites not listed yet · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Blood, fecal, saliva and intestinal content samples and biopsies to better understand how the disease works. Condition(s) listed: Crohn, Ulcerative Colitis (UC) and IBD (Inflammatory Bowel Disease).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- For all patients and control subjects
- Person able to give free and informed consent.
- Age ≥ 18 years.
Plus 10 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 4500 participants are expected to take part.
- Start date: 2025-09 (planned).
- Main results expected around 2040-11 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD (up to 12 months after the inclusion)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn; Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | Sorbonne University |
| Enrollment | 4500 (estimated) |
| Start date | 2025-09 |
| Primary completion (est.) | 2040-11 |
| First posted | 2025-09-15 |
| Last updated | 2025-09-15 |
| Official title | Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants |
| ClinicalTrials.gov ID | NCT07172945 |
Interventions
- Blood, fecal, saliva (Other)
Blood, fecal and saliva samples - intestinal content samples and biopsies (Other)
intestinal content samples and biopsies obtained per upper or lower gastrointestinal tract endoscopy
Full eligibility criteria (from the record)
Inclusion Criteria: 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 Criteria: 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).
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.