Healthy
Conditions
Brief summary
To develop a test to measure small bowel and colonic permeability.
Detailed description
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.
Interventions
small bowel and colonic permeability based on oral probe molecules and urine excretion in 60 healthy white, female and male adults aged 18-70y
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy * Non-Obese * Non-pregnant * Caucasian * BMI \<30kg/m2
Exclusion criteria
* Diabetes * Hypertension * BMI ≥30kg/m2 * Chronic NSAID use (\>3 days/week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Method to Measure Intestinal Permeability | 18 months | 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 |
Countries
United States