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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04262310
Enrollment
60
Registered
2020-02-10
Start date
2019-10-11
Completion date
2021-02-26
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

OTHERSmall Bowel and Colonic Permeability Test

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

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Standard Method to Measure Intestinal Permeability18 monthsNormal 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026