Specific probiotics in reducing the risk of acute infections in infancy – a randomised, double-blind, placebo-controlled study

British Journal of Nutrition
Q1
Nov 2008
Citations:228
Influential Citations:6
Interventional (Human) Studies
82
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Enhanced Details

Methods
Randomized, double-blind, placebo-controlled trial conducted in Turku, Finland. Healthy infants requiring infant formula before age 2 months were enrolled; chronic disease excluded. Eighty-one infants randomized (32 probiotic, 40 placebo); follow-up to 12 months with visits at 3, 7 and 12 months; infections tracked via diaries and clinical examinations.
Intervention
Daily supplementation with two probiotic strains, Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12, each at 1 × 10^10 colony-forming units per day, mixed into infant formula at one feeding, from enrollment before 2 months of age until 12 months.
Results
Probiotic supplementation reduced early acute otitis media and antibiotic use during the first 7 months: AOM 22% vs 50% (RR 0.44; 95% CI 0.21–0.90; P=0.014); antibiotic use 31% vs 60% (RR 0.52; 95% CI 0.29–0.92; P=0.015). It also reduced recurrent respiratory infections over 12 months (28% vs 55%; RR 0.51; 95% CI 0.27–0.95; P=0.022). Gastrointestinal infections were not significantly different (1/32 vs 6/40; P=0.091). No serious adverse effects. Authors conclude the probiotic combination may offer a safe, inexpensive means to reduce early infections and antibiotic use and to lower recurrent respiratory infections in full-term, formula-fed infants, though larger trials are warranted.
Limitations
Small sample size with 72 completers; wide confidence intervals; incomplete intention-to-treat analysis due to nine losses to follow-up; results may have limited generalizability to other populations or settings.

Abstract

A randomised, double-blind, placebo-controlled study was conducted to determine whether probiotics might be effective in reducing the risk of infections in infancy. Infants requiring formula before the age of 2 months were recruited from community we...