STUDY:

JOURNAL: Am J Clin Nutr. 2004;79:261-267

AUTHORS: Jose M. Saavedra

ABSTRACT: Probiotic-supplemented infant formula is well tolerated and safe, according to the results of a randomized, double-blind, placebo-controlled trial published in the February issue of the American Journal of Clinical Nutrition.

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Furthermore, treated infants had a lower rate of colic and use of antibiotics.

COMMENTARY: "Nonpathogenic live bacteria are consumed as food by many children, particularly in the form of yogurt," write Jose M. Saavedra, from the Johns Hopkins University School of Medicine in Baltimore, Maryland, and colleagues.

"The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented.... Adequate documentation of safety with prolonged use in infants is mandatory if recommendations for use are to be made in this population."

In this prospective study, 118 healthy infants aged three to 24 months were randomized to receive one of three standard milk-based formulas: formula containing 1 x 107 colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus, formula containing 1 x 106 CFU/g each of B. lactis and S. thermophilus, or unsupplemented formula.

At enrollment, mean age was 7.0 ± 2.9 months; the groups were similar in age, sex, and duration of formula consumption (mean, 210 ± 127 days). Compared with the unsupplemented formula, the supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability (P < .001) and of antibiotic use (P < .001).

Growth, utilization of healthcare services, daycare absenteeism, and other health variables were similar between groups.

"To our knowledge, this is the first careful documentation of intake of live bacteria over any extended period of time in any population. The intakes studied can be used as a benchmark for well-tolerated, safe intake of these bacterial agents," the authors write.

"Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and resulted in adequate growth, reduced reporting of colic or irritability, and a lower frequency of antibiotic use."

Nestlé USA supported this study and provided formulas.