Clinical trial NCT03376230: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
Official title: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Diseases
Keywords: Environmental risk factors
Xenobiotic detoxification
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility 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

Primary outcomes:
measure: Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.
timeFrame: Baseline
Other outcomes:
measure: Study of molecular origin and consequences of the genetic variability observed.
timeFrame: Baseline
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Pierre Desreumeaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: