Case-Control Study to Identify Risk Factors for Microscopic Colitis

Completed

• Conditions: Collagenous Colitis; Microscopic Colitis; Lymphocytic Colitis
• Interventions: Other: Whole saliva sample

• Registration Number: NCT01928667
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Study Start: 2014-07
• Primary Completion: 2016-06
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 487

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of environmental and hygiene-related risk factors for microscopic colitis	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

Secondary Outcome Measures

Name	Time	Method
The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors	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.

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Limburg, Netherlands