NCT00943345

Validation of New Tests for Gastrointestinal (GI) Permeability

Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-07-22
• Last updated: 2011-11-08

Locations

1 site across 1 country: Netherlands