Validation of New Tests for Gastrointestinal (GI) Permeability

Early Phase 1

• Conditions: Gastrointestinal Diseases
• Interventions: Drug: indometacin

• Registration Number: NCT00943345
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Study Start: 2009-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• healthy controls, female/male, 18-75 years of age, OR:
• coeliac disease without taking medicine, female/male, 18-75 years of age

Exclusion Criteria

• cardiac and/or vascular disease
• chronic obstructive pulmonary disease (COPD)
• rheumatic arthritis (RA)
• Inflammatory bowel disease(IBD); Crohn's colitis or colitis ulcerosa
• Irritable bowel syndrome (IBS)
• Inflammatory systemic disease
• Obesity (Body Mass Index ≥ 30 kg/m²)
• Diabetes Mellitus
• Thyroid disease
• Kidney disease
• Cancer
• Smoking
• Substance abuse (alcohol, drug, cocain, opioids, and others)
• Use of drugs
• Operations to the GI system, apart from appendectomy
• Allergy to eggs or milk
• Hypersensitivity to any of the following: lactulose, l-rhamnose, sucrose, sucralose of erythritol
• Acute porphyria or phenylketonuria (PKU)
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GS dual sugar permeability test	indometacin	Golden standard GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls). Coeliac patients will only have 1 test to assess basal GI permeability.
Multi sugar test	indometacin	New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls). Coeliac patients will only have 1 test to assess basal GI permeability.
Protein test	indometacin	New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls). Coeliac patients will only have 1 test to assess basal GI permeability.
PEG test	indometacin	New GI permeability test - testing occurs for basal permeability (with placebo) and after ingestion of indometacin (for normal controls). Coeliac patients will only have 1 test to assess basal GI permeability.

Primary Outcome Measures

Name	Time	Method
Comparison of permeability tests (new versus golden standard dual sugar test)	24 hours

Secondary Outcome Measures

Name	Time	Method
GI permeability	24 hours

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Zuid-Limburg, Netherlands