An observational study in Microscopic Colitis, Collagenous Colitis and Lymphocytic Colitis, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-19.
Sponsored by Maastricht University Medical Center · Observational
The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
Browse Colitis, Microscopic studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012
Other: Whole saliva sample
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.
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
Time frame: Retrospective, between 2000 and 2012
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.
Time frame: Retrospective between 2000 and 2012
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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