- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943345
Validation of New Tests for Gastrointestinal (GI) Permeability (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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Zuid-Limburg
-
Maastricht, Zuid-Limburg, Netherlands
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Other Names:
|
Other: 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. |
Other Names:
|
Other: 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. |
Other Names:
|
Other: 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. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of permeability tests (new versus golden standard dual sugar test)
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GI permeability
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: WA Buurman, Prof.dr., Maastricht University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Gastrointestinal Diseases
- Digestive System Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- MEC 09-3-034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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