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OpenTrials
Completed

NCT Number: NCT04262310

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Standard Method to Measure Intestinal Permeability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2020
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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