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

NCT04262310 | Completed

• 1 other identifier: 19-008541
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To develop a test to measure small bowel and colonic permeability.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Aims

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

Interventions

Small Bowel and Colonic Permeability Test OTHER

small bowel and colonic permeability based on oral probe molecules and urine excretion in 60 healthy white, female and male adults aged 18-70y

Study Aims

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

You may qualify if:

• Healthy
• Non-Obese
• Non-pregnant
• Caucasian
• BMI \<30kg/m2

You may not qualify if:

• Diabetes
• Hypertension
• BMI ≥30kg/m2
• Chronic NSAID use (\>3 days/week)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples for permeability measurements

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 10, 2020
• Study Start: October 11, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 26, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)