Researchers from Fonterra, the University of Otago, and the University of Auckland report that the two strains, administered to babies for their first two years of life, were not associated with any adverse events.
The new data is published in the International Dairy Journal, and is important for establishing the safety behind the ingredients.
According the FAO/WHO, probiotics are defined as "live microorganisms which when administered in adequate amounts confer a health benefit on the host".
Study details
The safety study was performed as part of a double-blind, placebo-controlled clinical trial for the reduction of risk for infant eczema, published previously in the Journal of Allergy and Clinical Immunology.
For the study, 446 pregnant women were recruited and randomly assigned to take daily supplements of L. rhamnosus HN001, B. animalis subsp lactis strain HN019 or placebo from 35 weeks gestation and for a further six months if breastfeeding. The infants received the same interventions from birth to two years of age. Both strains were provided by Fonterra Co-operative Group, which also co-sponsored the study along with the Health Research Council of New Zealand.
All children were considered at ‘high-risk’ of inheriting eczema due to a family history of allergic disease.
The researchers report no statistically significant differences between the probiotic groups and the placebo group in terms of withdrawal from the study, the incidence of adverse events, and the use of antibiotics during the study period.
“Analysis of the results showed that consumption of the probiotics daily from birth for two years had no effect on measures of general growth, health, and tolerance,” wrote lead author James Dekker from Fonterra Innovation.
“The conclusion from the safety endpoints of the study were that both B. animalis subsp. lactis HN019 and L. rhamnosus HN001 were safe and well tolerated when given to infants from birth.”
Controversy for eczema
In October of last year, NutraIngredients.com reported the results from the clinical trial. While no effects were observed for the Bifidobacterium, supplementation with L. rhamnosus strain HN001 was associated with less severe symptoms of eczema.
“There has been controversy about whether probiotics prevent the development of eczema,” wrote the authors in the Journal of Allergy and Clinical Immunology. “Our study provides further evidence that L rhamnosus is indeed an effective intervention for reducing the prevalence of eczema among high-risk children.”
Source: International Dairy JournalVolume 19, Issue 3, Pages 149-154“Safety aspects of probiotic bacterial strains Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. lactis HN019 in human infants aged 0–2 years”Authors: J.W. Dekker, K. Wickens, P.N. Black, T.V. Stanley, E.A. Mitchell, P. Fitzharris, G.W. Tannock, G. Purdie, J. Crane