Publication of a safety and tolerance study for probiotic strains in infants

A team from Madrid University (Spain) has just published a multi-centre randomized, double-blind, placebo-controlled intervention study regarding the safety and tolerance of three of LHS probiotic strains in healthy infants. The strains tested individually are Lactobacillus helveticus Rosell®-52, Bifidobacterium infantis Rosell®-33, Bifidobacterium bifidum Rosell®-71, all part of the ProbioKid® formula, previously shown to help prevent the reoccurrence of winter infections in children. The eight weeks intervention study involved a large population sample as 221 healthy infants (3-12 months of age) were recruited in total, divided between four groups (placebo and each of the three probiotic strains). No serious adverse events were reported and the Spanish authors concluded that the use of the three probiotic strains in infancy is safe, and well tolerated.
Bérengère Feuz, Marketing Group Manager, commented about the study: “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 (e.g. China where it is a best-selling probiotic formula for children since 2003). This study reinforces the assurance we have in our product. Moreover, I must say that we are very impressed by the quality and impact of this very-well designed study as it involves a large population of healthy infants and assesses independently each of the individual strains of Probio’Stick.” She added: “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”.
Such safety study contributed to the GRAS (Generally Recognized as Safe) status recently obtained in the US for both ProbioKid® formula and its individual strains for infants and children, and the approval by Health Canada of the formula for children from 3 months old.