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Impact of Probiotic Use on Immune Cell Function in Children

NCT02687503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-12-24

No results posted yet for this study

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

Conditions

  • Respiratory Tract Infections

Interventions

DIETARY_SUPPLEMENT

Probiotic

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.

Sponsors & Collaborators

  • Danisco

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-11-29
Completion
2019-03-08

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 NCT02687503 on ClinicalTrials.gov