NCT01724203

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Fonterra Research Centre · Industry
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

Summary

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

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

• Effect of Probiotics on Infections in Infants.

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus rhamnosus
DIETARY_SUPPLEMENT	Bifidobacterium animalis subsp. lactis
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-11-09
• Last updated: 2013-10-11

Locations

1 site across 1 country: China