Effect of Probiotics on Infections in Infants. Clinical Trial
Official title:
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months: a Double-blind, Randomized, Placebo-controlled Study.
The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.
Probiotics are live bacteria that offer a health benefit to the host when administered via
the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the
elderly and has demonstrated beneficial effects for a wide variety of health conditions such
as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel
disease. The immune-enhancing benefits of probiotics are attractive, particularly for
infants, a group that is particularly prone to a variety of infections, e.g. respiratory
tract infection, strep throat, and diarrhea. Probiotic supplementation has been utilized in
previous studies of childhood infections with promising results.
In this study, the safety and effectiveness of 12-week probiotic supplementation on the
incidence and duration of infectious episodes in infants aged 6 to 12 months will be
determined. The subjects will receive follow-on formula containing 1 million CFU/g
Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis
subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day
for 12 weeks.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research