Case-Control Study to Identify Risk Factors for Microscopic Colitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01928667
First received: August 21, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Microscopic Colitis
Collagenous Colitis
Lymphocytic Colitis
Other: Whole saliva sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk Factors for Microscopic Colitis: A Dutch Case-Control Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Assessment of environmental and hygiene-related risk factors for microscopic colitis [ Time Frame: Retrospective, between 2000 and 2012 ] [ Designated as safety issue: No ]
    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:
  • The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors [ Time Frame: Retrospective between 2000 and 2012 ] [ Designated as safety issue: No ]

    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.



Biospecimen Retention:   Samples With DNA

saliva samples


Estimated Enrollment: 900
Study Start Date: July 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928667

Locations
Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01928667     History of Changes
Other Study ID Numbers: NL44127.068.13
Study First Received: August 21, 2013
Last Updated: August 4, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Colitis
Colitis, Collagenous
Colitis, Microscopic
Colitis, Lymphocytic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014