Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability

Study Overview
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Brief Summary
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To develop a test to measure small bowel and colonic permeability.

Detailed Description
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The study consists of a physical examination, standardized meals and 3 oral sugar tests with 24 hour urine collections. It requires the participants to visit the Clinical Research Trials Unit in the Charlton Building and Domitilla Building. Remuneration will be offered.

Official Title
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Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability

Conditions
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Healthy

Intervention / Treatment
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* Other: Small Bowel and Colonic Permeability Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Non-Obese Non-pregnant Caucasian BMI <30kg/m2 Exclusion Criteria: Diabetes Hypertension BMI ≥30kg/m2 Chronic NSAID use (>3 days/week)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Aims<br>To obtain normative data (median, 10th and 90th percentile) as well as inter-individual coefficient of variation (COV, assessed by [SD/mean]) with approximately 15 participants in each age group: 18-30, 31-45, 46-60, and 60-70 years old. To assess intra-individual COV [assessed by [SD/mean]. To assess effect of standard diets containing 16.25 or 32.5 g fiber/day during the two 24 hour periods before and during the measurement of permeability | Other: Small Bowel and Colonic Permeability Test<br>* small bowel and colonic permeability based on oral probe molecules and urine excretion in 60 healthy white, female and male adults aged 18-70y<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Method to Measure Intestinal Permeability | Normal data on intestinal permeability in a Healthy human cohort: To summarize, using descriptive statistics, the median, 95% confidence interval, interquartile range of the following: Urine excretion of probe molecules at 0-2h (reflecting small bowel permeability) with primary interest in 13C-mannitol and rhamnose Urine excretion of probe molecules at 8-24h (reflecting colonic permeability) with primary interest in lactulose and sucralose Urine excretion of probe molecules at 2-8h reflecting both small intestinal and colonic permeability As part of the effort to ascertain conditions under which the test would be performed in the future, we shall test the intra-individual coefficient of variation in healthy individuals, when the test is performed twice under conditions of identical diet, and when the test is performed with diets that have standardized but different quantities of fiber | 18 months |