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

Microscopic Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303132
• Other study ID #: NL48505.068.14
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: July 18, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Microscopic Colitis

Intervention

Other:
• Ussing experiment
fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Transepithelial electircal resistance		2 hours	No
Secondary	Change in permeation of a fluorescent marker		2 hours	No