Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Maastricht University Medical Center Top Institute Food and Nutrition |
---|---|
Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00943345 |
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 |
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
|
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
|
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
|
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
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Zuid-Limburg | |
Maastricht University Medical Center | |
Maastricht, Zuid-Limburg, Netherlands |
Principal Investigator: | WA Buurman, Prof.dr. | Maastricht University Medical Center |
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) |
GI gastrointestinal permeability |
indometacin indomethacin coeliac |
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 |
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 |