Impact of Probiotic Use on Immune Cell Function in Children

Not Applicable

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT02687503
• Lead Sponsor: University of Wisconsin, Madison

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Study Start: 2017-05-15
• Primary Completion: 2017-11-29
• Status Verified: 2019-03
• Study Completion: 2019-03-08
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daily dose of probiotic	Probiotic	All children enrolled into the study will receive a daily dose of probiotic

Primary Outcome Measures

Name	Time	Method
Innate immune cell multiparameter flow cytometry assay	3 months	The primary measurement will be plasmacytoid dendritic cell responses to various TLR agonists (CpGA, R848) and intact human rhinovirus. Variables measured will include pDC frequency, frequency of IFN-alpha and TNF-alpha producing cells and geometric mean fluorescence intensity of these cytokines using an optimized and standardized multi-parameter flow cytometry assay.

Secondary Outcome Measures

Name	Time	Method
Isolation of peripheral blood mononuclear cells (PBMC) by density gradient	3 months	Multi-parameter flow cytometry will be used to determine the frequency of CD25+CD127-/loFoxp3+CD4+ T cells. Function will be indirectly CD25+ determined by quantifying the level of TSDR demethylation in Treg cells.

Trial Locations

Locations (2)

UW Health 20 S. Park Clinic; 🇺🇸 Madison, Wisconsin, United States

UW Health West Towne Clinic; 🇺🇸 Madison, Wisconsin, United States