Case-Control Study to Identify Risk Factors for Microscopic Colitis

NCT ID: NCT01928667

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-07-31

Brief Summary

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The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.

Detailed Description

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Conditions

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Microscopic Colitis Collagenous Colitis Lymphocytic Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Microscopic Colitis

Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012

Whole saliva sample

Intervention Type OTHER

Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.

Healthy Controls

Control group consists of subjects with no history of microscopic colitis. Group is age and sex matched with the case-group

Whole saliva sample

Intervention Type OTHER

Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.

Interventions

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Whole saliva sample

Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed Diagnosis of MC (CC or LC) between January 1, 2000 and December 31, 2012.
* Inhabitant of the province of Limburg or the Eindhoven region at the moment of diagnosis

Exclusion Criteria

* Below 18 years of age at the time of diagnosis
* Not capable of signing an informed consent
* Deceased at moment of approximation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marieke J Pierik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Daisy MAE Jonkers, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Ad AM Masclee, Prof.

Role: STUDY_DIRECTOR

Maastricht UMC

Locations

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Maastricht UMC

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL44127.068.13

Identifier Type: -

Identifier Source: org_study_id

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