NCT02687503

Impact of Probiotic Use on Immune Cell Function in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	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.

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-11-29
• Completion: 2019-03-08
• First posted: 2016-02-22
• Last updated: 2019-12-24

Locations

2 sites across 1 country: United States