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Validation of New Tests for Gastrointestinal (GI) Permeability

NCT00943345 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-11-08

No results posted yet for this study

Summary

Introduction: The primary function of the gastrointestinal (GI) wall is digestion and absorption of nutrients that are important for growth and development. The second important function of the GI wall is forming an effective barrier to prevent penetration of potentially harmful components from the inside of the gut (lumen), via the GI wall, into the body.

A compromised barrier function may play an important role in the development of a range of inflammatory GI diseases such as coeliac disease, Inflammatory Bowel Disease (IBD), food allergy, but also in the pathophysiology of postoperative complications. It is important and clinically relevant to have reliable GI permeability tests, however the existing test leave room for improvement.

Rationale/aim: Three new tests are developed to assess gastrointestinal permeability in both normal controls with and without raised permeability, and in patients with coeliac disease. In the current study these new permeability tests will be evaluated and compared with the golden standard permeability test, the dual sugar test.

Conditions

  • Gastrointestinal Diseases

Interventions

DRUG

indometacin

* capsule for oral consumption * at 22h00 evening before test day: 75 mg * at 7h30 on the test day: 50 mg This intervention will be applied 4 times (4 arms).

Sponsors & Collaborators

  • Top Institute Food and Nutrition

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • WA Buurman, Prof.dr. · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943345 on ClinicalTrials.gov