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Study of an Environmental Risk Factor in Crohn's Disease

NCT ID: NCT04960826

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-27

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn's disease patients

No interventions assigned to this group

Non IBD patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Agency, France

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe ZERBIB, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Lille University Hospital

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe ZERBIB, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Cécile Vignal

Role: primary

Other Identifiers

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2020_11

Identifier Type: -

Identifier Source: org_study_id

2020-A02380-39

Identifier Type: OTHER

Identifier Source: secondary_id