Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes (EXPOSOMES)

September 15, 2020 updated by: University Hospital, Lille
the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • CHU Lille
        • Principal Investigator:
          • Corinne Gower, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication.

Description

Inclusion Criteria:

  • adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication

Exclusion Criteria:

  • smokers during 10 last years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
high incidence crohn's disease area
subjects living in high incidence crohn's disease area coming in dentist for dental extraction linked to medical indication
low incidence crohn's disease area
subjects living in low incidence crohn's disease area coming in dentist for dental extractionlinked to medical indication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Time Frame: Baseline: one session
Baseline: one session

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison of environmental exposomes using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
Time Frame: Baseline: one session
Baseline: one session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Corinne GOWER, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_44
  • 2018-A00195-50 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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