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NCT03611400 · ClinicalTrials.gov registry record · NA

The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

A NA study of Intestinal Barrier Function, sponsored by University of Florida.

Completed
Registry status
NA
Development phase
39
Enrollment target
1
Study location

NCT03611400: Completed NA study of Intestinal Barrier Function, sponsored by University of Florida.

NCT03611400 is a NA study of Intestinal Barrier Function that has completed, run by University of Florida. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03611400, a NA study of Intestinal Barrier Function, has completed, sponsored by University of Florida.

COMPLETED
Registry status
NA
Development phase
39 participants
Enrollment target
1
Study location

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.

Primary Outcome

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

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Probiotic

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2018-08-22
Est. Completion 2019-04-15
Phase NA
University of Florida

1,106 total trials

What the finished NCT03611400 record still lists

NCT03611400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Intestinal Barrier Function appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03611400 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT03611400 about?

NCT03611400 is a clinical study titled "The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults". 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 ...

What is the current status of trial NCT03611400?

This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2018-08-22. Estimated completion is 2019-04-15.

What conditions does trial NCT03611400 study?

This clinical trial studies the following conditions: Intestinal Barrier Function.

What interventions are being tested in trial NCT03611400?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotic (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03611400?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03611400 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03611400's enrollment target sits among peer trials

39 1536th of 2000 higher than 463 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03611400, the US trial registry maintained by the National Library of Medicine. NCT03611400 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.