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

Mayo Clinic

Status: Completed

Conditions: Healthy

Treatments: Other: Small Bowel and Colonic Permeability Test

Study type: Observational

Funder types: Other

Identifiers

NCT04262310

19-008541

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

60 participants in 1 patient group

Study Aims

Description:

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

Treatment:

Other: Small Bowel and Colonic Permeability Test