Microscopic ColitisNCT01928667
Case-Control Study to Identify Risk Factors for Microscopic Colitis
An observational study of Microscopic Colitis and Collagenous Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microscopic Colitis, Collagenous Colitis, Lymphocytic Colitis
- What is being tested?
- Whole saliva sample
- How many people
- 487 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Below 18 years of age at the time of diagnosis
- Not capable of signing an informed consent
- Deceased at moment of approximation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Microscopic Colitis: A Dutch Case-Control Study
The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.
- Being tested
- Whole saliva sample
- Medical subject headings
- Colitis, Microscopic, Colitis, Collagenous, Colitis, Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole saliva sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Microscopic Colitis | Group consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012 Receives: 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 Receives: Other: Whole saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Retrospective between 2000 and 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marieke J Pierik, MD, PhD, Principal investigator, Maastricht UMCDaisy MAE Jonkers, PhD, Principal investigator, Maastricht UniversityAd AM Masclee, Prof., Study director, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928667
- Sponsor's protocol ID
- NL44127.068.13
- Status last verified
- Jul 2016
- First submitted
- 21 Aug 2013
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Microscopic Colitis: A Dutch Case-Control Study
- ClinicalTrials.gov ID
- NCT01928667
- Acronym / sponsor ID
- NL44127.068.13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess among others environmental and hygiene-related risk factors for microscopic colitis (MC), a common diarrheal disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microscopic Colitis | – | Other: Whole saliva sampleGroup consists of subjects diagnosed with either collagenous of lymphocytic colitis between January 1, 2000 and December 31, 2012 |
| Healthy Controls | – | Other: Whole saliva sampleControl group consists of subjects with no history of microscopic colitis. Group is age and sex matched with the case-group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Below 18 years of age at the time of diagnosis
- Not capable of signing an informed consent
- Deceased at moment of approximation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole saliva sampleBoth 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. | Other | Healthy Controls, Microscopic Colitis |
Primary outcome
Assessment of environmental and hygiene-related risk factors for microscopic colitis
Time frame: 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
1 secondary outcome
The difference between the CC and LC subpopulation regarding environmental, hygiene-related, and generally known risk factors
Time frame: Retrospective between 2000 and 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marieke J Pierik, MD, PhD principal investigator
Maastricht UMC
Daisy MAE Jonkers, PhD principal investigator
Maastricht University
Ad AM Masclee, Prof. study director
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microscopic Colitis and Collagenous Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of environmental and hygiene-related risk factors for microscopic colitis (time frame: Retrospective, between 2000 and 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.