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The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

NCT03611400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-06-21

No results posted yet for this study

Summary

In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut permeability will be assessed weekly using food-grade sugar molecules. On the second week, participants will take aspirin, which will make their intestine permeable to the sugars. Participants will be asked to provide urine and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the probiotic.

Conditions

  • Intestinal Barrier Function

Interventions

DIETARY_SUPPLEMENT

Probiotic

This probiotic is commercially available and contains L. helveticus R0052 (0.2 x 10\^9 CFU/capsule) and L. rhamnosus R0011 (3.8 x 10\^9 CFU/capsule) as active ingredients and ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide, and maltodextrin as excipients.

DIETARY_SUPPLEMENT

Placebo

The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Bobbi Langkamp-Henken, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03611400 on ClinicalTrials.gov