NCT04960826 Study of an Environmental Risk Factor in Crohn's Disease
| NCT ID | NCT04960826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-27 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-09-27 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Inflammatory bowel disease (IBD) are lifelong chronic diseases affecting the gastrointestinal tract. The precise etiology and the different actors participating to the pathophysiological process leading to the disease development are still not well understood. A complex interaction between genetics, gut microbiota and environmental factors is thought to trigger the inappropriate mucosal immune response observed in IBD patients. We hypothesize that DON might be an environmental risk factor for IBD.The focus on the human relevance of the gut effects of DON by studying its exposure, metabolism and adverse effects in health and disease focusing on IBD patients
Eligibility Criteria
Inclusion Criteria: * Group 1: patients with ileocolic Crohn's disease requiring surgery * Group 2: Patients requiring ileal and / or colonic surgery for a reason other than Crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum). Exclusion Criteria: * Vegetarian or vegan patients, celiac disease, gluten sensitivity, eating disorders, people with a particular diet or eating behavior or suffering from obesity or anorexia * Surgical history: patient having undergone intestinal resection * Current treatments: patient receiving antibiotic or probiotic treatment within 6 weeks prior to inclusion / patient having taken topical treatment (suppositories or enema of 5ASA or corticosteroids) within 6 weeks prior to inclusion
Contact & Investigator
Philippe ZERBIB, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04960826 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 60 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04960826 currently recruiting?
Yes, NCT04960826 is actively recruiting participants. Contact the research team at philippe.zerbib@chru-lille.fr for enrollment information.
Where is the NCT04960826 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04960826 clinical trial?
NCT04960826 is sponsored by University Hospital, Lille. The principal investigator is Philippe ZERBIB, MD,PhD at University Hospital, Lille. The trial plans to enroll 100 participants.