Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability
- Conditions
- Healthy
- Interventions
- Other: Small Bowel and Colonic Permeability Test
- Registration Number
- NCT04262310
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Healthy
- Non-Obese
- Non-pregnant
- Caucasian
- BMI <30kg/m2
- Diabetes
- Hypertension
- BMI ≥30kg/m2
- Chronic NSAID use (>3 days/week)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Aims Small Bowel and Colonic Permeability Test 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States