NCT03376230

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. 1.As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
  2. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

9 years

First QC Date

December 12, 2017

Last Update Submit

February 12, 2019

Conditions

Inflammatory Bowel Diseases

Keywords

Environmental risk factorsXenobiotic detoxification

Outcome Measures

Primary Outcomes (1)

  • Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.

    Baseline

Secondary Outcomes (1)

  • Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.

    Baseline

Other Outcomes (1)

  • Study of molecular origin and consequences of the genetic variability observed.

    Baseline

Study Arms (3)

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

Interventions

Collect of blood, urines, and intestinal biopsiesOTHER
Control patientsCrohn's disease patientsUlcerative colitis patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients who are at least 18 years old
  • 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)
  • Patients requiring coloscopy as part of their medical follow-up
  • Social insured.

You may not qualify if:

  • Pregnant women
  • Breastfeeding women
  • People in emergency
  • Persons unable to understand, read and / or sign informed consent
  • Patients who recently had an intercurrent episode (eg recent diarrhea ...)
  • Persons deprived of their liberty
  • Persons protected by a legal protection status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal mucosal biopsies Blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Pierre Desreumeaux, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 18, 2017

Study Start

February 1, 2010

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

FR(1)