Consumption of the probiotic strains, Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071 and Lactobacillus helveticus R0052, in healthy infants aged 3 to 12 months did not affect growth and did not trigger any side effects.
The bacterial strains form part of Lallemand Health Solutions (LHS) Probio’Kid formula, which has already received a health claims approvals in Canada back in 2013.
Earlier this month, the formula received the Generally Recognized as Safe (GRAS) status for use in the US and Canada amongst young children.
“This study reinforces the assurance we have in our product,” said Bérengère Feuz, Lallemand’s marketing group manager.
“We already have a track record of safe use of our Probio’Kid formula as it has been marketed for around 15 years around the world. In China, it is a best-selling probiotic formula for children since 2003.
“The protocol allowed to go beyond the safety and tolerance assessment since many parameters were also included: this will be analysed in a second step and shall give us new information about each strain modes of action in healthy individuals such as interactions with the microbiota and immune system.”
Lallemand Health Solutions is no stranger to a worldwide probiotic supplement and food market worth around $45bn (€40bn) according to Euromonitor.
The global ingredient supplier has over 40 documented probiotic strains in its portfolio that include the Bifidobacterium and Lactobacillus genera, arguably the most widely used probiotic bacteria in functional foods and dietary supplements.
Their use are particularly evident in infants either as a single-species or as a multi-species product.
Administration either in supplements or in follow-on infant formula given beyond early infancy may be associated with certain health benefits.
A team from Madrid University in Spain performed the eight-week intervention study, which received support from Lallemand Health Solutions.
It involved 221 healthy infants aged 3-12 months of age. These infants were divided between four groups.
Here, the infants received either a placebo or one of the 3 probiotic strains (3×109 colony forming units (cfu)) daily.
Growth (weight, height and head circumference), adverse events (AEs)/serious adverse events (SAEs), concentrations of D-lactic acid in urine samples, characteristics of the stools and use of medication were collected for safety evaluation.
All four groups were identical in age, gender, feeding type, ethnicity, height, and weight and head circumference at the start of the study.
The results showed that changes in growth (weight, height and head circumference) were similar in all four groups.
No SAEs were reported and total number of AEs recorded were equivalent in all groups.
“These results are in accordance with those observed in other studies, further supporting the safety of certain lactobacilli and bifidobacteria strains and promoting their use as probiotics,” the study commented.
Safe D-lactic acid levels
Of particular interest were levels of D-lactic acid in urine samples.
The overgrowth of gram-positive anaerobes such as lactobacilli can result in excess production of lactate.
Symptoms can include confusion, ataxia, slurred speech, and altered mental status.
“In this work, the levels of D-lactate in the urine samples analysed were below the quantification limit of the method, 33 micromols (µM) or 3.6 – 105 millimols/mol of creatinine, considering reference ranges of creatinine in infants less than 2 years of life,” the study added.
Despite the positive opinion garnered in the US and Canada, Lallemand Health Solutions have had less success in Europe.
In 2012 the Probio’Kid formula was unsuccessful in receiving a health claim approval by the European Food and Safety Authority (EFSA).
The claimed effect was Probiokid’s beneficial contribution to immune defence against pathogen in the general population.
The Panel concluded that a cause and effect relationship had not been established between the consumption of a combination of the bacterial strains.
Source: Beneficial Microbes
Published online ahead of print: DOI 10.3920/BM2017.0009
“Safety and tolerance of three probiotic strains in healthy infants. A multi-centre randomized, double-blind, placebo-controlled trial.”
Authors: S. Manzano, J. De Andrés, I. Castro, J.M. Rodríguez, E. Jiménez and I. Espinosa-Martos.