Back to resultsUssing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Primary Purpose
Microscopic Colitis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Ussing experiment
Sponsored by
About this trial
This is an interventional basic science trial for Microscopic Colitis
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Active MC
MC in remission
Controls
Arm Description
Patients with active MC will be included
Patients with MC in remission will be included
Patients without MC will be included
Outcomes
Primary Outcome Measures
Change in Transepithelial electircal resistance
Secondary Outcome Measures
Change in permeation of a fluorescent marker
Full Information
NCT ID
NCT02303132
First Posted
November 25, 2014
Last Updated
July 18, 2016
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02303132
Brief Title
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
Official Title
Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microscopic Colitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active MC
Arm Type
Other
Arm Description
Patients with active MC will be included
Arm Title
MC in remission
Arm Type
Other
Arm Description
Patients with MC in remission will be included
Arm Title
Controls
Arm Type
Other
Arm Description
Patients without MC will be included
Intervention Type
Other
Intervention Name(s)
Ussing experiment
Intervention Description
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
Primary Outcome Measure Information:
Title
Change in Transepithelial electircal resistance
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change in permeation of a fluorescent marker
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Masclee, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
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