Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706196
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Environmental Exposure

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706196


Contacts
Layout table for location contacts
Contact: Corinne GOWER, MD,PhD 03 20 44 55 18 ext +33 corinne.gower@chru-lille.fr

Locations
Layout table for location information
France
CHU lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Corinne Gower, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Corinne GOWER, MD,PhD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03706196    
Other Study ID Numbers: 2017_44
2018-A00195-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
dental exposome
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases