Case-Control Study to Identify Risk Factors for Microscopic Colitis

NCT01928667 | Completed DMC

• 1 other identifier: NL44127.068.13
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 1

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.

Conditions

Microscopic Colitis; Collagenous Colitis; Lymphocytic Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors

  Retrospective between 2000 and 2012

Study Arms (2)

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

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

Interventions

Whole saliva sample 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; Microscopic Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Below 18 years of age at the time of diagnosis
• Not capable of signing an informed consent
• Deceased at moment of approximation

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples

MeSH Terms

Conditions

Colitis, Microscopic; Colitis, Collagenous; Colitis, Lymphocytic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marieke J Pierik, MD, PhD

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

• Daisy MAE Jonkers, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Ad AM Masclee, Prof.

  Maastricht UMC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

NL (1)