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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
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: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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]
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).
Other Name: Indometacin [Actavis]
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).
Other Name: Indometacin [Actavis]
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).
Other Name: Indometacin [Actavis]

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943345

Locations
Netherlands
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 by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim van Wijck, MD, PhD student, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00943345     History of Changes
Other Study ID Numbers: MEC 09-3-034
Study First Received: July 21, 2009
Last Updated: November 7, 2011
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

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

ClinicalTrials.gov processed this record on September 22, 2014