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

Inflammatory Bowel Diseases Clinical Trial

— CHIMICI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03376230
• Other study ID #: 2009_13
• Secondary ID: 2010-A00056-33
• Status: Terminated
• Start date: February 2010
• Est. completion date: January 24, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Collect of blood, urines, and intestinal biopsies

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study of molecular origin and consequences of the genetic variability observed.		Baseline
Primary	Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.		Baseline
Secondary	Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.		Baseline