Environmental exposure to DON and its possible role in Crohn's disease
dEoxyniValenol as Risk Factor for Inflammatory Bowel Diseases: Human detoxifiCaTion and Impact On intestiNal Microbiota and Homeostasis
This study will test whether exposure to the food contaminant DON affects gut exposure, metabolism, and harm in people with ileocolic Crohn's disease compared with people having similar bowel surgery for other reasons.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04960826 on ClinicalTrials.gov |
What this trial studies
This is an observational study focused on the human relevance of DON (deoxynivalenol) gut effects by measuring exposure, metabolism, and adverse effects in people with ileocolic Crohn's disease and in control patients undergoing ileal and/or colonic surgery for non-IBD reasons. Participants are grouped into Crohn's patients requiring surgery and non-IBD surgical controls to allow comparison of DON-related markers. Key exclusions include vegetarian/vegan diets, celiac disease or gluten sensitivity, prior intestinal resection, and recent antibiotic, probiotic, or topical 5-ASA/corticosteroid use. Data will be collected around the time of surgery to characterize DON exposure and its gut effects in health and disease.
Who should consider this trial
Good fit: Adults scheduled for ileal and/or colonic surgery who have ileocolic Crohn's disease or are undergoing similar surgery for non-IBD reasons, who do not follow restrictive diets, have no prior intestinal resection, and have not taken antibiotics, probiotics, or topical 5-ASA/corticosteroids in the past six weeks.
Not a fit: People not undergoing the specified surgery, or those with celiac disease, gluten sensitivity, vegetarian/vegan diets, recent antibiotic/probiotic or topical IBD treatments, prior intestinal resections, or ulcerative colitis are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If a link between DON exposure and Crohn's-related gut changes is found, patients could receive practical guidance to reduce exposure and inform prevention strategies.
How similar studies have performed: Animal and laboratory studies suggest DON can affect the gut, but human data on DON as a Crohn's risk factor are limited, so this human-focused approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille
- Lille University Hospital — Lille, France (Recruiting)
Study contacts
- Principal investigator: Philippe ZERBIB, MD,PhD — University Hospital, Lille
- Study coordinator: Philippe ZERBIB, MD,PhD
- Email: philippe.zerbib@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.