Impact of Probiotic Use on Immune Cell Function in Children

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

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy children greater than 12 months-36 months of age
English speaking parent
Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks

Exclusion criteria

Asthma/allergic rhinitis
Premature birth (< 36 weeks gestation)
Known to be lactose intolerant
Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks
Currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days
Any antibiotic treatment in the last 2 weeks
Conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract
Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Treatment and study plan

Probiotic

Dietary Supplement

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.

Primary outcomes

Innate immune cell multiparameter flow cytometry assay

Time frame: 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 outcomes

Isolation of peripheral blood mononuclear cells (PBMC) by density gradient

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Danisco

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2019
First posted: Feb 22, 2016
Registry last updated: Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed