For the first time a health authority recognizes that probiotics, particularly Lallemand Health Solutions strains Bifidobacteria infantis Rosell®-33, and Bifidobacteria bifidum Rosell®-71, can help formula-fed babies develop a similar microflora as to breast-fed infants.
These unprecedented Canadian Health claims (1) are:
B. infantis Rosell®-33
- Helps to maintain a baby-like microflora in infants (for formula-fed infants).
- Helps to balance formula-fed baby’s microflora similar to breast-fed infants.
B. bifidum Rosell®-71
- Helps to maintain a baby-like microflora in infants (for formula-fed infants).
- Helps to balance formula-fed baby’s microflora similar to breast-fed infants.
“Our R&D and Regulatory teams strike again! 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. This is a huge step in demonstrating that our probiotics can contribute to support normal gut and immune maturation in early life.” commented Solange Henoud, Vice-president, Regulatory and Compliance at Lallemand Health Solutions. “This news is the icing on the cake! Indeed the U.S. Food and Drug Administration (FDA) 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 Canadian 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.
Focus on a supportive key study
In a randomized, double-blind, placebo-controlled study [Manzano, 2017], B. infantis Rosell®-33 was deemed safe and well tolerate in 221 healthy three- to twelve-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: maintain a baby-specific microbiome profile rich in bacteria able to digest lactose such as Bifidobacteria, regardless of any influencing factors (diets, birth mode, etc.). By opposition, in the placebo group, there were a significant increase in common constituents of healthy adult gut microbiota, and a decrease of Bifidobacteria (most specifically bifidum and B. breve).
It also tends to increase the anti-inflammatory IL-10/IL-12 ratio during the 8-week period of intake, whereas placebo turns towards a pro-inflammatory state.
Formulation and Innovation
Both strains can be formulated in adapted galenic formats such as sachets, sticks and drops or in raw powder to be added directly in infant formulas, opening doors to great innovations.
More information
The intestinal microflora of infants should contain a high proportion of Bifidobacteria during their first year of life to be well preserved and balanced and to maintain a healthy gut development and integrity to help them better digest milk. Growing up, until their third year, infants will acquire and develop their microflora until they reach a more stable stage. The two bifidobacteria strains, (B. infantis Rosell®-33 and B. bifidum Rosell®-71) encourage a smooth and timely evolution of the microflora from birth up to three years old, when the microflora reaches an adult-like stage.
[1] Health Canada NPN 80114767 and 80114768
