Validation of New Tests for Gastrointestinal (GI) Permeability

Study Overview
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Brief Summary
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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.

Official Title
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Dubbelblind Crossover Study for Validation of New Tests for Gastrointestinal (GI) Permeability

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Drug: indometacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GS dual sugar permeability test<br>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<br>* 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).<br>* Other names: Indometacin [Actavis];|
| Other: Multi sugar test<br>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<br>* 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).<br>* Other names: Indometacin [Actavis];|
| Other: Protein test<br>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<br>* 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).<br>* Other names: Indometacin [Actavis];|
| Other: PEG test<br>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<br>* 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).<br>* Other names: Indometacin [Actavis];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of permeability tests (new versus golden standard dual sugar test) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI permeability |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI, gastrointestinal, permeability, indometacin, indomethacin, coeliac