Safety and tolerance of L. reuteri in early infancy

This was a prospective, randomised, double blind and placebo-controlled study with the objective to evaluate the safety of two probiotic strains in healthy full-term infants. The 59 infants were 3-65 days old at enrolment and for four weeks they were given humanized cow’s milk formula (control group, n=19), the same formula with Bifidobacterium lactis Bb-12 (n=20) or Lactobacillus reuteri ATCC 55730 (n=20). Breast-feeding had ceased prior to inclusion in the study (parents’ own decision). The mean daily intake of each of the probiotic strains was 1.2 x 10⁹ CFU. Each participant underwent a physical examination at baseline and at four weeks. The parents filled out a daily questionnaire for seven days during the first and fourth week of the trial for documentation of feeding, behaviour and stools’ characteristics. The parents were also instructed to report daily on every complaint or symptom.

No clinical adverse effects were seen during the trial and the growth, feeding, behaviour and stools’ characteristics were the same in the three groups.

Conclusion: Both probiotic strains were well tolerated during the four weeks study in these very young infants and no clinical adverse effects were seen.

Reference

Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study. Weizman Z, Alsheik A. (2006) J Am Coll Nutr 25:415-419.