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

NCT ID: NCT03376230

Last Updated: 2019-02-15

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

TERMINATED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2019-01-24

Brief Summary

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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

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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

CROSS_SECTIONAL

Study Groups

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Control patients

Collect of blood, urines, and intestinal biopsies

Intervention Type OTHER

Crohn's disease patients

Collect of blood, urines, and intestinal biopsies

Intervention Type OTHER

Ulcerative colitis patients

Collect of blood, urines, and intestinal biopsies

Intervention Type OTHER

Interventions

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Collect of blood, urines, and intestinal biopsies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Desreumeaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00056-33

Identifier Type: OTHER

Identifier Source: secondary_id

2009_13

Identifier Type: -

Identifier Source: org_study_id

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