Role of the Chemical Environment in the Pathogenesis of I... | NCT03376230

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

NCT03376230

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

Feb 15, 2019Actual

Enrollment

148Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Collect of blood, urines, and intestinal biopsies

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-A00056-33	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough recruitment

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Jan 24, 2019Actual

Completion Date

Jan 24, 2019Actual

First Submitted Date

Dec 12, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Collect of blood, urines, and intestinal biopsies	Other		Control patients Crohn's disease patients Ulcerative colitis patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.		Baseline

Other Outcomes

Measure	Description	Time Frame
Study of molecular origin and consequences of the genetic variability observed.		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Desreumeaux, MD, PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU, Hôpital Claude Huriez		Lille			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided