Validation of New Tests for Gastrointestinal (GI) Permeability

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Kim van Wijck, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00943345
First received: July 21, 2009
Last updated: November 7, 2011
Last verified: November 2011

July 21, 2009
November 7, 2011
September 2009
February 2012   (final data collection date for primary outcome measure)
Comparison of permeability tests (new versus golden standard dual sugar test) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00943345 on ClinicalTrials.gov Archive Site
GI permeability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Validation of New Tests for Gastrointestinal (GI) Permeability
Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Gastrointestinal Diseases
Drug: 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 Name: Indometacin [Actavis]
  • Active Comparator: 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.

    Intervention: Drug: indometacin
  • 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.

    Intervention: Drug: indometacin
  • 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.

    Intervention: Drug: indometacin
  • 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.

    Intervention: Drug: indometacin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
34
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00943345
MEC 09-3-034
Yes
Kim van Wijck, Maastricht University Medical Center
Maastricht University Medical Center
Top Institute Food and Nutrition
Principal Investigator: WA Buurman, Prof.dr. Maastricht University Medical Center
Maastricht University Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP