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Impact of Probiotic Use on Immune Cell Function in Children

Primary Purpose

Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring Immune system, Probiotics

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • UW Health 20 S. Park Clinic
  • UW Health West Towne Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Daily dose of probiotic

Arm Description

All children enrolled into the study will receive a daily dose of probiotic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 25, 2016
Last Updated
December 23, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Danisco
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1. Study Identification

Unique Protocol Identification Number
NCT02687503
Brief Title
Impact of Probiotic Use on Immune Cell Function in Children
Official Title
Impact of Probiotic Use on Immune Cell Function in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Danisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
Immune system, Probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily dose of probiotic
Arm Type
Other
Arm Description
All children enrolled into the study will receive a daily dose of probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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 Outcome Measure Information:
Title
Innate immune cell multiparameter flow cytometry assay
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Isolation of peripheral blood mononuclear cells (PBMC) by density gradient
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
UW Health 20 S. Park Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
UW Health West Towne Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Impact of Probiotic Use on Immune Cell Function in Children

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