- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04960826
Study of an Environmental Risk Factor in Crohn's Disease (EVICTION)
December 18, 2025 updated by: University Hospital, Lille
dEoxyniValenol as Risk Factor for Inflammatory Bowel Diseases: Human detoxifiCaTion and Impact On intestiNal Microbiota and Homeostasis
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
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philippe ZERBIB, MD,PhD
- Phone Number: +33 0320445962
- Email: philippe.zerbib@chru-lille.fr
Study Locations
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-
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Lille, France
- Recruiting
- Lille University Hospital
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Contact:
- Cécile Vignal
- Email: cecile.vignal2@univ-lille.fr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- 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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Crohn's disease patients
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Non IBD patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quantification of Deoxynivalenol and its conjugated metabolites by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS).
Time Frame: through study completion, an average of 2 years
|
through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe ZERBIB, MD,PhD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2021
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
July 1, 2021
First Submitted That Met QC Criteria
July 13, 2021
First Posted (Actual)
July 14, 2021
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020_11
- 2020-A02380-39 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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