The primary objective is to assess environmental, hygiene-related risk factors for MC. Secondary objectives are the difference between the CC and LC subpopulation regarding hygiene-related risk factors, living area as potential risk factor and the…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the assessment of environmental, hygiene-related
risk factors for MC.
Secondary outcome
Secondary parameters are the difference between the CC and LC subpopulation
regarding hygiene-related risk factors, living area as potential risk factor
and the assessment of the more generally known risk factors (e.g. age, gender,
smoking, medication).
A specific outcome is the risk of exposure to polution in the living area,
based on longitudinal residential data (GIS substudy).
Background summary
Microscopic colitis (MC) includes two main subtypes: lymphocytic colitis and
collagenous colitis. MC is characterized by chronic, non-bloody, watery
diarrhea and a normal appearing colonic mucosa, though with typical
histological inflammatory changes. Although generally considered as a benign
condition, MC has a chronic sustained course in the majority of patients and is
associated with an impairment of health related quality of life.
Over the years several risk factors have been identified for MC. These were
mainly generally known risk factors such as gender, age, comorbidities and
smoking. Besides, some specific medicines, e.g. proton-pump inhibitors and
NSAID*s, have also been found to increase the risk of MC. No research has ever
been performed to identify environmental, hygiene-related risk factors for MC.
In inflammatory bowel disease the hygiene hypothesis has gained interest. The
hypothesis states that a decreased antigenic exposure in childhood could be the
cause of an immunological over-reaction at the time of a following microbial
contact. In this light it would be interesting to investigate whether this
hypothesis is also applicable to MC.
Study objective
The primary objective is to assess environmental, hygiene-related risk factors
for MC. Secondary objectives are the difference between the CC and LC
subpopulation regarding hygiene-related risk factors, living area as potential
risk factor and the assessment of the more generally known risk factors (e.g.
age, gender, smoking, medication).
Furthermore, the association between polution in the living area and the risk
of MC will specifically be addressed (GIS-substudy).
Study design
Case-control study
Study burden and risks
Neither patients nor controls will gain direct benefit from participation. The
burden of the study mainly consist of the consumption of time and effort to
fill out the questionnaire and to collect the swabs. There is no risk in
completing the questionaire. The risk of buccal swab collection is very low.
The technique is easy and safe. Beisdes, a clear instruction about how to
collect the material will be added.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Patients:
- diagnosed with microscopic/collagenous/lymphocytic colitis between 2000 and 2012; .
- inhabitant of Limburg / Eindhoven region at time of diagnosis.;Controls:
- never diagnosed with microscopic/collagenous/lymphocytic colitis;
- participant in 'IBD-ZL controlecohort'
Exclusion criteria
Patients + controls
- Age below 18 years at the time of diagnosis
- Not capable of signing an informed consent
- Deceased
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44127.068.13 |