Validation of New Tests for Gastrointestinal (GI) Permeability
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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 |
- Comparison of permeability tests (new versus golden standard dual sugar test) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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
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
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
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
Other Name: Indometacin [Actavis]
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Zuid-Limburg, Netherlands | |
| 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 Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013