Impact of Probiotic Use on Immune Cell Function in Children

Study Overview
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Brief Summary
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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

Official Title
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Impact of Probiotic Use on Immune Cell Function in Children

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Daily dose of probiotic<br>All children enrolled into the study will receive a daily dose of probiotic | Dietary Supplement: Probiotic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Innate immune cell multiparameter flow cytometry assay | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation of peripheral blood mononuclear cells (PBMC) by density gradient | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune system, Probiotics