supports safety of probiotic ingredients
By Stephen Daniells,
Source of Article: http://www.dairyreporter.com/Safety-Hygiene/Fonterra-supports-safety-of-probiotic-ingredients
The probiotic strains Lactobacillus rhamnosus
HN001 and Bifidobacterium animalis subsp. lactis
HN019 are safe and well-tolerated, according to a new study from New Zealand.
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".
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
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
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 placebo 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
“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.”
Volume 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