Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 19, 2016
July 1, 2016
7 months
November 25, 2014
July 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Transepithelial electircal resistance
2 hours
Secondary Outcomes (1)
Change in permeation of a fluorescent marker
2 hours
Study Arms (3)
Active MC
OTHERPatients with active MC will be included
MC in remission
OTHERPatients with MC in remission will be included
Controls
OTHERPatients without MC will be included
Interventions
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
Eligibility Criteria
You may qualify if:
- The indication for colonoscopy is a relapse of MC (active) / MC in remission (remission) / no MC (control)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
A Masclee, PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
November 27, 2014
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
July 19, 2016
Record last verified: 2016-07