Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease (CHIMICI)

February 12, 2019 updated by: University Hospital, Lille

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • CHRU, Hôpital Claude Huriez

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

600 divided into 3 groups:

  • 200 patients with ulcerative colitis
  • 200 patients with Crohn's disease
  • 200 control patients not suffering from inflammatory bowel disease and whose follow-up requires the realization of a coloscopy

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crohn's disease patients
Other: Collect of blood, urines, and intestinal biopsies
Control patients
Other: Collect of blood, urines, and intestinal biopsies
Ulcerative colitis patients
Other: Collect of blood, urines, and intestinal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.
Time Frame: Baseline
Baseline

Other Outcome Measures

Outcome Measure
Time Frame
Study of molecular origin and consequences of the genetic variability observed.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

February 1, 2010

Primary Completion (ACTUAL)

January 24, 2019

Study Completion (ACTUAL)

January 24, 2019

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009_13
  • 2010-A00056-33 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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