Case-Control Study to Identify Risk Factors for Microscopic Colitis

July 18, 2016 updated by: Maastricht University Medical Center

Risk Factors for Microscopic Colitis: A Dutch Case-Control Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

487

Contacts and Locations

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

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht UMC

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The case group will be selected by a retropective search in the pathology registry. Subjects have to be diagnosed between January 1, 2000 and December 31, 2012; have to be older than 18 years of age and have to be living in the province of Limburg, the Netherlands.

Healthy controls are selected via the municipal personal records databases in the same region.

Description

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Microscopic Colitis
Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012
Other: 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.
Healthy Controls
Control group consists of subjects with no history of microscopic colitis. Group is age and sex matched with the case-group
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of environmental and hygiene-related risk factors for microscopic colitis
Time Frame: Retrospective, between 2000 and 2012
Information about environmental and hygiene-related risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012
Retrospective, between 2000 and 2012

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors
Time Frame: Retrospective between 2000 and 2012

As generally known risk factors are considered: age, gender, medication, comorbidities and smoking.

Information about risk factors is obtained by a questionnaire, sent to subjects diagnosed with MC between 2000 and 2012.
Retrospective between 2000 and 2012

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Marieke J Pierik, MD, PhD, Maastricht UMC
  • Principal Investigator: Daisy MAE Jonkers, PhD, Maastricht University
  • Study Director: Ad AM Masclee, Prof., Maastricht UMC

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

July 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL44127.068.13

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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