Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study

Abstract

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.

• infant formula
• probiotics
• safety
• tolerance

The authors are thankful to Drora Leader and Chaim Zegerman of Materna Laboratories for their kind help and cooperation. They also thank Ilana Gelernter, from the Statistics Laboratory, Tel Aviv University, for the careful statistical analysis. In addition they are also thankful to the research team and the infants with their parents for making this study possible.

Notes

The study was supported by a research grant from Materna Laboratories, Maabarot, Israel.

Some of the study data were presented at the American Pediatric Societies Meeting, Seattle, Washington, May 2003, and at the European Society of Parenteral and Enteral Nutrition Annual Meeting, Cannes, France, September 2003. They appear in abstract form in Pediatr Res 53:174A, 2003, and in Clin Nutr 22:S69, 2003.