Clinical trial NCT00943345: Validation of New Tests for Gastrointestinal (GI) Permeability
Official title: Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Diseases
Keywords: GI
gastrointestinal
permeability
indometacin
indomethacin
coeliac
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2009-07-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Comparison of permeability tests (new versus golden standard dual sugar test)
timeFrame: 24 hours
Secondary outcomes:
measure: GI permeability
timeFrame: 24 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Zuid-Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: WA Buurman, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Wijck K, Verlinden TJ, van Eijk HM, Dekker J, Buurman WA, Dejong CH, Lenaerts K. Novel multi-sugar assay for site-specific gastrointestinal permeability analysis: a randomized controlled crossover trial. Clin Nutr. 2013 Apr;32(2):245-51. doi: 10.1016/j.clnu.2012.06.014. Epub 2012 Aug 11.