Case-Control Study to Identify Risk Factors for Microscopic Colitis

Microscopic Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928667
• Other study ID #: NL44127.068.13
• Status: Completed
• Phase: N/A
• First received: August 21, 2013
• Last updated: July 18, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Collagenous Colitis
• Lymphocytic Colitis
• Microscopic Colitis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of environmental and hygiene-related risk factors for microscopic colitis	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	No
Secondary	The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors	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	No