Full Text View
Tabular View
No Study Results Posted
Related Studies
Validation of New Tests for Gastrointestinal (GI) Permeability
This study is not yet open for participant recruitment.
Verified by Maastricht University Medical Center, July 2009
First Received: July 21, 2009   No Changes Posted
Sponsors and Collaborators: Maastricht University Medical Center
Top Institute Food and Nutrition
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00943345
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Diseases
Drug: indometacin
Phase 0

Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Comparison of permeability tests (new versus golden standard dual sugar test) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GI permeability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GS dual sugar permeability test: Active Comparator
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.
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).
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.
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).
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.
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).
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.
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943345

Locations
Netherlands, Zuid-Limburg
Maastricht University Medical Center
Maastricht, Zuid-Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: WA Buurman, Prof.dr. Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center ( Prof.dr. W.A.Buurman )
Study ID Numbers: MEC 09-3-034
Study First Received: July 21, 2009
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00943345     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
GI
gastrointestinal
permeability
indometacin
indomethacin
coeliac

Study placed in the following topic categories:
Anti-Inflammatory Agents
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Diseases
Cyclooxygenase Inhibitors
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Celiac Disease
Cardiovascular Agents
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions
Digestive System Diseases
Tocolytic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009