Validation of New Tests for Gastrointestinal (GI) Permeability
NCT ID: NCT00943345
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
34 participants
INTERVENTIONAL
2009-09-30
2012-02-29
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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GS dual sugar permeability test
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.
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).
Multi sugar test
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.
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).
Protein test
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.
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).
PEG test
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.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* coeliac disease without taking medicine, female/male, 18-75 years of age
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Kim van Wijck
MD, PhD student
Principal Investigators
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WA Buurman, Prof.dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands
Countries
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References
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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.
Other Identifiers
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MEC 09-3-034
Identifier Type: -
Identifier Source: org_study_id