Validation of New Tests for Gastrointestinal (GI) Permeability
Information source: Maastricht University Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Diseases
Intervention: indometacin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Maastricht University Medical Center Official(s) and/or principal investigator(s):
WA Buurman, Prof.dr., Principal Investigator, Affiliation: Maastricht University Medical Center
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.
Clinical Details
Official title: Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability
Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Comparison of permeability tests (new versus golden standard dual sugar test)
Secondary outcome: GI permeability
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Maastricht University Medical Center, Maastricht, Zuid-Limburg, Netherlands
Additional Information
Starting date: September 2009
Ending date: December 2012
Last updated: July 21, 2009
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