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

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ClinicalTrials.gov Identifier: NCT03376230
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Other: Collect of blood, urines, and intestinal biopsies

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
Actual Study Start Date : February 2010
Estimated Primary Completion Date : January 24, 2019
Estimated Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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



Primary Outcome Measures :
  1. Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients. [ Time Frame: Baseline ]

Other Outcome Measures:
  1. Study of molecular origin and consequences of the genetic variability observed. [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Intestinal mucosal biopsies Blood


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376230


Contacts
Contact: Pierre Desreumeaux, MD,PhD pdesreumaux@hotmail.com

Locations
France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Pierre Desreumaux, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Pierre Desreumeaux, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03376230     History of Changes
Other Study ID Numbers: 2009_13
2010-A00056-33 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Environmental risk factors
Xenobiotic detoxification

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis