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

July 18, 2016 updated by: Maastricht University Medical Center

Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Active MC
Patients with active MC will be included
Other: Ussing experiment
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
OTHER: MC in remission
Patients with MC in remission will be included
Other: Ussing experiment
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
OTHER: Controls
Patients without MC will be included
Other: Ussing experiment
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Transepithelial electircal resistance
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in permeation of a fluorescent marker
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Chair: A Masclee, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (ESTIMATE)

November 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL48505.068.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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