Ex vivo experiments to evaluate the role of medication on the colon permeability in microscopic colitis

Completed

Conditions: microscopic bowel inflammation
microscopic colitis
10017969

Registration Number: NL-OMON41154

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

In general: aged between 50-75 years, no current use of NSAIDs, PPIs or SSRIs.
* For patients in remission: positive diagnosis of microscopic, in remission under medication
* For patients with active disease: positive diagnosis of microscopic, collagenous or lymphocytic colitis; confirmed active disease due to relapse, no recent treatment for MC
* For healthy controls: no prior positive diagnosis of microscopic, collagenous or lymphocytic colitis.

Exclusion Criteria

- Age below 18 years at the time of diagnosis
- Use of anticoagulants or immunosuppressive drugs
- Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and any co-morbidity hindering an endoscopic procedure)
- A previous history of any type of chronic colitis (other than MC), irritable bowel syndrome, colon carcinoma or (partial) colectomy
- A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
- Use of medication known for influencing intestinal permeability
- Excessive alcohol usage (>20 standard units per week)
- Not capable of signing an informed consent
- Defaecation diary is not matching the predefined stool frequency for the designated patient group (active, remission, control)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the difference in colon permeability<br /><br>(transpeithelial electrical resistance and FITC-permeation) caused by<br /><br>administration of risk medication between the three groups (MC active, MC<br /><br>remission, MC control)</p><br>

Secondary Outcome Measures