The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

Not Applicable

Completed

• Conditions: Intestinal Barrier Function
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT03611400
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-02
• Study Start: 2018-08-22
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 capsules daily for 3 weeks containing the same carrier material and is similar in size, shape and taste to probiotic (group is unknown, double blinded)
Probiotic	Probiotic	2 capsules daily for 3 weeks, containing 3.8 x 10\^9 CFU (colony forming units)/capsule of Lactobacillus rhamnosus strain R011and 0.2 x 10\^9 CFU/capsule of L. helveticus strain R0052 (group is unknown, double blinded)

Primary Outcome Measures

Name	Time	Method
Gastroduodenal Permeability	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 Outcome Measures

Name	Time	Method
Whole Gut Permeability	Weeks 1 and 2 on each intervention	difference in the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 0 to 24-hour urine collection with the probiotic versus the placebo interventions
Small Intestinal Permeability	Weeks 1 and 2 on intervention	Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in urinary lactulose/rhamnose ratio in the 0 to 5-hour urine collection with the probiotic versus the placebo interventions.
Colonic Permeability	Weeks 1 and 2 on intervention	Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 5 to 24-hour urine collection with the probiotic versus the placebo interventions.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States