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

U

University Hospital, Lille

Status

Terminated

Conditions

Inflammatory Bowel Diseases

Treatments

Other: Collect of blood, urines, and intestinal biopsies

Study type

Observational

Funder types

Other

Identifiers

NCT03376230
2009_13
2010-A00056-33 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

148 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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