Study of an Environmental Risk Factor in Crohn's Disease

NCT04960826 | Recruiting

• 2 other identifiers: 2020_112020-A02380-39
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Crohn's disease patients

Non IBD patients

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Research Agency, France: collaborator

Study Sites (1)

Lille University Hospital

Lille, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Philippe ZERBIB, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ZERBIB, MD,PhD

CONTACT

0320445962; philippe.zerbib@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 14, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)