CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Probioticdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02687503
NCT02687503N/ACompleted

Impact of Probiotic Use on Immune Cell Function in Children

University of Wisconsin, Madison·interventional·Posted Feb 22, 2016·Updated Dec 24, 2019

In Brief

A clinical study evaluating Probiotic for Respiratory Tract Infections. Completed, enrolled 23 participants across 2 sites.

Detailed Summary

Probiotics are microorganisms that are believed to provide health benefits when consumed. The term probiotic is currently used to name ingested microorganisms associated with beneficial effects to humans and animals. Probiotics are popularized in the lay literature for many different clinical problems. They have been studied in infants and children as a preventive or treatment for a variety of infections. Studies on the medical benefits of probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be conclusively proven for most of the studies conducted thus far. The putative benefit of probiotics in the prevention of infection relates to potential benefits to the innate and adaptive immune systems of infants. The goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics. To accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDanisco

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 22, 2016
Enrollment StartMay 15, 2017
Primary CompletionNov 29, 2017
Study CompletionMar 8, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.4 years ago

Interventions

Probioticdietary

All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.