Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease

Terminated

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Collect of blood, urines, and intestinal biopsies

• Registration Number: NCT03376230
• Lead Sponsor: University Hospital, Lille

Brief Summary

Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.

The aims of this clinical trial are:

1. As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.

2. As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Patients who are at least 18 years old
2. Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or "Control" patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)
3. Patients requiring coloscopy as part of their medical follow-up
4. Social insured.

Exclusion Criteria

1. Pregnant women
2. Breastfeeding women
3. People in emergency
4. Persons unable to understand, read and / or sign informed consent
5. Patients who recently had an intercurrent episode (eg recent diarrhea ...)
6. Persons deprived of their liberty
7. Persons protected by a legal protection status

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's disease patients	Collect of blood, urines, and intestinal biopsies	-
Ulcerative colitis patients	Collect of blood, urines, and intestinal biopsies	-
Control patients	Collect of blood, urines, and intestinal biopsies	-

Primary Outcome Measures

Name	Time	Method
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.	Baseline

Secondary Outcome Measures

Name	Time	Method
Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.	Baseline

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France