Study of an Environmental Risk Factor in Crohn's Disease
Observational · No treatment assigned · 1 site · University Hospital, Lille
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 25 to 60
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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).
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2021-09-27.
- Main results expected around 2026-07 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Quantification of Deoxynivalenol and its conjugated metabolites by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS). (through study completion, an average of 2 years)
In the researchers’ words
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.
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | University Hospital, Lille |
| Collaborators | National Research Agency, France |
| Enrollment | 100 (estimated) |
| Start date | 2021-09-27 |
| Primary completion (est.) | 2026-07 |
| First posted | 2021-07-14 |
| Last updated | 2025-12-26 |
| Official title | dEoxyniValenol as Risk Factor for Inflammatory Bowel Diseases: Human detoxifiCaTion and Impact On intestiNal Microbiota and Homeostasis |
| ClinicalTrials.gov ID | NCT04960826 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Lille University Hospital | Lille | France | Recruiting |
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.