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Lallemand receives approval from Health Canada for probiotic strains for infants

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Two of the probiotic strains from Lallemand Health Solutions have been approved for two Canadian health claims, paving the way for the strains to be marketed as helping babies develop similar small intestine flora to breastfed infants.

These claims for Bifidobacteria infantis Rosell-33 and Bifidobacteria bifidum Rosell-71 include:

  • Helps maintain infant-like bacteria (for formula-fed infants
  • Helps balance bacteria that formula feeds on like breastfed babies


At the heart of this health claim are two studies. The first is a randomized, double-blind, placebo-controlled study, where B. infant Rosell-33 was considered safe and well tolerated in 221 healthy infants aged 3 to 12 months.

A post-hoc analysis, based on a sample of infants from the 2017 Manzano study, demonstrated B. infant Rosell-33 can maintain a child’s microbiome profile rich in lactose-digesting bacteria such as Bifidobacteria, regardless of any influencing factors such as diet, birth position, etc.

On the other hand, the placebo group showed a significant increase in common components of a healthy adult gut microbiome, and a decrease in bifidobacteria. In addition, the anti-inflammatory IL-10/IL-12 ratio increased during the eight-week period of drug administration, while the placebo group switched to a more pro-inflammatory state.

“Science and carefully done work over the past years evaluating the safety and beneficial effect of these strains on children’s microflora continues to receive official recognition. This is a major step in demonstrating that our probiotics can contribute to supporting normal gut and immune maturation in early life, “said Solange Henoud, Vice President, Regulation and Compliance at Lallemand Health Solutions.