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

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ClinicalTrials.gov Identifier: NCT02303132
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Microscopic Colitis Other: Ussing experiment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ex Vivo Experiments to Evaluate the Role of Medication on the Colon Permeability in Microscopic Colitis
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. Change in Transepithelial electircal resistance [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Change in permeation of a fluorescent marker [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303132


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Chair: A Masclee, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02303132    
Other Study ID Numbers: NL48505.068.14
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Colitis
Colitis, Microscopic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases