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Clinical Trials/NCT03611400
NCT03611400
Completed
Not Applicable

The Effect of Probiotic Intake on Intestinal Permeability of Healthy Adults

University of Florida1 site in 1 country39 target enrollmentAugust 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intestinal Barrier Function
Sponsor
University of Florida
Enrollment
39
Locations
1
Primary Endpoint
Gastroduodenal Permeability
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 22, 2018
End Date
April 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gastroduodenal Permeability

Time Frame: Week 2 of each intervention

The primary outcome is the difference between the changes in gastroduodenal permeability induced by aspirin challenge with the probiotic versus the placebo. Gastroduodenal permeability will be assessed while on the placebo and probiotic interventions by measuring urinary sucrose in the 0 to 5-hour urine collection of the sugar probe permeability test. Change will be calculated as the urinary sucrose concentration after aspirin challenge (week 2 of each intervention) minus the concentration from the prior week (i.e., 1 wk on intervention with no aspirin challenge).

Secondary Outcomes

  • Whole Gut Permeability(Weeks 1 and 2 on each intervention)
  • Small Intestinal Permeability(Weeks 1 and 2 on intervention)
  • Colonic Permeability(Weeks 1 and 2 on intervention)

Study Sites (1)

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