09.13.22
Lallemand Health Solutions’ two probiotic strains, Bifidobacteria infantis Rosell-33 and Bifidobacteria bifidum Rosell-71, received approvals from Health Canada to be marketed as being able to help formula-fed babies develop a similar microflora as breast-fed infants. This is the first time that Health Canada has recognized probiotics can achieve this activity.
Health Canada’s claims for both strains are: “helps to maintain a baby-like microflora in infants (for formula-fed infants)”; and “helps to balance formula-fed baby’s microflora similar to breast-fed infants.”
“The science and work carefully achieved during the past years assessing the safety and beneficial impact of these strains on a baby-specific microflora continue to receive official acknowledgements,” said Solange Henoud, vice president of regulatory and compliance at Lallemand Health Solutions. “This is a huge step in demonstrating that our probiotics can contribute to support normal gut and immune maturation in early life. This news is icing on the cake. Indeed the U.S. Food and Drug Administration had previously formally and publicly endorsed that the usage of these specific strains in infants’ formula is Generally Recognized as Safe (GRAS). An achievement that was followed by several other health authorities, under different jurisdictions, such as the listing by the Chinese authorities and Canadaian Food Directorate as a new infant formula ingredient – needless to say that these lists are very narrow and only few specific strains are permitted for such use,” she added.
Supported by Clinical Research
In a randomized, double-blind, placebo-controlled study, [Manzano, 2017] B. infantis Rosell-33 was deemed safe and well-tolerated in 221 healthy three- to 12-month-old infants.
A post-hoc analysis [De Andres, 2018], based on a sample of infants from the Manzano 2017 study, showed B. infantis Rosell-33 can maintain a baby-specific microbiome profile rich in bacteria able to digest lactose such as Bifidobacteria, regardless of any influencing factors such as diets, birth mode, etc.
By opposition, in the placebo group, there was a significant increase in common constituents of healthy adult gut microbiota, and a decrease of Bifidobacteria. It also tends to increase the anti-inflammatory IL-10/IL-12 ratio during the eight week period of intake, while the placebo group turned toward a more pro-inflammatory state.
Both strains can be formulated in galenic formats such as sachets, sticks, and drops, or in raw powder form to be added directly in infant formulas.
Health Canada’s claims for both strains are: “helps to maintain a baby-like microflora in infants (for formula-fed infants)”; and “helps to balance formula-fed baby’s microflora similar to breast-fed infants.”
“The science and work carefully achieved during the past years assessing the safety and beneficial impact of these strains on a baby-specific microflora continue to receive official acknowledgements,” said Solange Henoud, vice president of regulatory and compliance at Lallemand Health Solutions. “This is a huge step in demonstrating that our probiotics can contribute to support normal gut and immune maturation in early life. This news is icing on the cake. Indeed the U.S. Food and Drug Administration had previously formally and publicly endorsed that the usage of these specific strains in infants’ formula is Generally Recognized as Safe (GRAS). An achievement that was followed by several other health authorities, under different jurisdictions, such as the listing by the Chinese authorities and Canadaian Food Directorate as a new infant formula ingredient – needless to say that these lists are very narrow and only few specific strains are permitted for such use,” she added.
Supported by Clinical Research
In a randomized, double-blind, placebo-controlled study, [Manzano, 2017] B. infantis Rosell-33 was deemed safe and well-tolerated in 221 healthy three- to 12-month-old infants.
A post-hoc analysis [De Andres, 2018], based on a sample of infants from the Manzano 2017 study, showed B. infantis Rosell-33 can maintain a baby-specific microbiome profile rich in bacteria able to digest lactose such as Bifidobacteria, regardless of any influencing factors such as diets, birth mode, etc.
By opposition, in the placebo group, there was a significant increase in common constituents of healthy adult gut microbiota, and a decrease of Bifidobacteria. It also tends to increase the anti-inflammatory IL-10/IL-12 ratio during the eight week period of intake, while the placebo group turned toward a more pro-inflammatory state.
Both strains can be formulated in galenic formats such as sachets, sticks, and drops, or in raw powder form to be added directly in infant formulas.
