Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Effect of Probiotics on Infections in Infants.

Keywords

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Probiotics for infants Bacterial and viral infections in infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactobacillus rhamnosus

Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.

Group Type ACTIVE_COMPARATOR