Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis

Not Applicable

Completed

• Conditions: Microscopic Colitis
• Interventions: Other: Ussing experiment

• Registration Number: NCT02303132
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Medication use, especially NSAIDs and PPIs, prior to diagnosis is considered a risk factor for MC development. However, the exact pathophysiological mechanism is unclear. It is hypothesized that NSAIDs, PPIs, and SSRIs may have an effect on the colon permeability, due to an idiosyncratic reaction which results in a local immune response. MC patients are considered to be susceptible hosts, prone to react on administration of abovementioned drugs. In order to test this hypothesis and to generate new insights in the pathophysiology of MC, we want to perform an Ussing chamber experiment using fresh colon tissue samples. The primary objective is to assess ex vivo the effect of NSAIDs and PPIs on epithelial permeability of colon biopsy specimens of MC and non-MC patients, using the Ussing chamber system

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-27
• Study Start: 2015-11
• Primary Completion: 2016-06
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
• Patient is not treated with NSAIDs / PPI / SSRI in week before inclusion

Exclusion Criteria

• Age below 18 years at the time of diagnosis
• Use of anticoagulants or immunosuppressive drugs
• Severe co-morbidities hindering an endoscopic procedure
• A previous history of any type of chronic colitis, IBS, IBD, colon carcinoma or (partial) colectomy
• A recent (last year) diagnosis of infectious diarrhea or radiation proctitis.
• Use of medication known to influence intestinal permeability
• Excessive alcohol usage (>20 standard units per week)
• Not capable of signing an informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MC in remission	Ussing experiment	Patients with MC in remission will be included
Active MC	Ussing experiment	Patients with active MC will be included
Controls	Ussing experiment	Patients without MC will be included

Primary Outcome Measures

Name	Time	Method
Change in Transepithelial electircal resistance	2 hours

Secondary Outcome Measures

Name	Time	Method
Change in permeation of a fluorescent marker	2 hours

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands