Impact of Probiotic Use on Immune Cell Function in Children

Respiratory Tract Infections Clinical Trial

Official title:

Impact of Probiotic Use on Immune Cell Function in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687503
• Other study ID #: 2015-0884
• Secondary ID: A536700SMPH\PEDI
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: March 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 8, 2019
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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).

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Probiotic
All children will receive a daily dose of probiotic (10? 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.

Locations

Country	Name	City	State
United States	UW Health 20 S. Park Clinic	Madison	Wisconsin
United States	UW Health West Towne Clinic	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Danisco

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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