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

Study answer

What this study found

Probiotic supplementation was associated with fewer acute infections and less antibiotic use during infancy, with the strongest signal in early and recurrent respiratory outcomes. Early infections within the first 7 months occurred in 7/32 (22%) versus 20/40 (50%) in placebo (RR 0.44, 95% CI 0.21 to 0.90; P = 0.014), antibiotic use in 10/32 (31%) versus 24/40 (60%) (RR 0.52, 95% CI 0.29 to 0.92; P = 0.015), and recurrent respiratory infections in 9/32 (28%) versus 22/40 (55%) (RR 0.51, 95% CI 0.27 to 0.95; P = 0.022). Tympanostomy was not statistically significant (0/32 vs 4/40; P = 0.066),…

Study & population

Randomized, double-blind, placebo-controlled trial in infants needing formula before 2 months of age and not exclusively breast-fed.

Intervention

Infants in the active arm received a daily oral probiotic supplement added to infant formula: Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12, each at 1 x 10^10 colony-forming units per day, delivered in visually identical capsules and continued until 12 months of age.

Key limitation

The active arm was small, with only 32 infants randomized and 72 of 81 infants completing follow-up overall, limiting precision and safety inference.

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Original abstract