Safety aspects of probiotic bacterial strains Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. lactis HN019 in human infants aged 0–2 years

• Published in: International dairy journal Vol. 19; no. 3; pp. 149 - 154
• Main Authors: Dekker, James W., Wickens, Kristin, Black, Peter N., Stanley, Thorsten V., Mitchell, Edwin A., Fitzharris, Penny, Tannock, Gerald W., Purdie, Gordon, Crane, Julian
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.2009; [Amsterdam]: Elsevier Science; Elsevier
• Subjects: adverse effects; antibiotics; Bifidobacterium animalis; Biological and medical sciences; clinical trials; Food industries; Fundamental and applied biological sciences. Psychology; General aspects; Hygiene and safety; infant formulas; infant growth; infants; lactating women; Lactobacillus rhamnosus; Milk and cheese industries. Ice creams; mothers; pregnant women; probiotics; species differences; strain differences; Human; Probiotic; Lactic acid bacteria; Bifidobacterium; Eubacteria; Bifidobacteriaceae; Strain; Actinobacteridae; Dairy industry; Actinobacteria; Bacteria; Lactobacillaceae; Bifidobacteriales; Safety; Lactobacillus
• ISSN: 0958-6946; 1879-0143
• DOI: 10.1016/j.idairyj.2008.10.004

Given the relatively immature state of the neonatal gut and gut-associated immune system, the safety of probiotic strains for use as ingredients in infant milk formulae must be demonstrated in infant populations. As part of a double-blind placebo-controlled clinical trial of two commercially available probiotic strains in the reduction of risk for infant eczema, a number of safety outcomes were measured. Infants received daily doses of Lactobacillus rhamnosus HN001 (6 × 10 9 cfu day −1) or Bifidobacterium animalis subsp. lactis HN019 (9 × 10 9 cfu day −1), or placebo from birth to 24 months. Mothers received the same treatment from 35 weeks gestation, for up to 6 months postnatally while breastfeeding. No statistically significant differences were observed between the treatment groups for study withdrawal, incidence of adverse events, morphometric data, wheeze, and antibiotic use over the treatment period. We conclude that probiotics strains HN001 and HN019 were safe and well tolerated in infants, and did not affect normal growth.