Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: A pilot study

Objective: To compare the safety and tolerance of two formulas, supplemented with different probiotic agents, in early infancy. Design: Prospective randomized placebo-controlled trial. Setting: Clinics of a University Medical Center. Subjects: Full-term healthy infants aged less than 4 months. Intervention: Infants were randomly assigned for 4 weeks to a standard milk-based formula supplemented with either Bifidobacterium lactis (BB- 12), Lactobacillus reuteri (ATCC 55730) or a probiotics-free formula. Measures of Outcome: Growth parameters, daily characteristics of feeding, stooling and behavior, and side effects. Results: Fifty-nine infants, aged 3-65 days, were included. Subjects in all three groups were similar at entry in terms of gestational age, birth weight, sex, growth parameters and breast feeding rate prior to the study. The supplemented formulas were well accepted and did not reveal any adverse effects. A comparison of growth parameters, and variables of feeding, stooling and crying and irritability did not reveal any significant differences between groups. Conclusions: The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy, was safe, well tolerated and did not adversely affect growth, stooling habits or infant behavior.