Validation of New Tests for Gastrointestinal (GI) Permeability
Permeability
Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2009
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 8, 2011
November 1, 2011
2.4 years
July 21, 2009
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of permeability tests (new versus golden standard dual sugar test)
24 hours
Secondary Outcomes (1)
GI permeability
24 hours
Study Arms (4)
GS dual sugar permeability test
ACTIVE COMPARATORGolden 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
OTHERNew 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
OTHERNew 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
OTHERNew 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.
Interventions
* 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).
Eligibility Criteria
You may qualify if:
- healthy controls, female/male, 18-75 years of age, OR:
- coeliac disease without taking medicine, female/male, 18-75 years of age
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands
Related Publications (1)
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.
PMID: 22892368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WA Buurman, Prof.dr.
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 22, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 8, 2011
Record last verified: 2011-11