The infant gut microbiota plays a fundamental role in digestive health, immune development, and overall well-being during the first years of life. As the intestinal microbiome develops, nutrition becomes one of the most important factors influencing its composition.
Among the probiotic strains studied in infant nutrition, Bifidobacterium animalis subsp. lactis BB-12® is one of the most extensively researched. Clinical studies have demonstrated its safety and its potential to support digestive function, immune health, gut microbiota development, and overall infant comfort.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. These beneficial bacteria play a crucial role in establishing and maintaining a healthy gut microbiota, particularly during the early stages of life when an infant's digestive and immune systems are rapidly developing.
In the context of infant nutrition, probiotics are increasingly recognized as valuable components that can support digestive comfort, immune function, and overall wellness.
BB-12® is the abbreviation for Bifidobacterium animalis subsp. lactis BB-12® and is the world’s most documented probiotic. BB-12® is described in more than 200 human clinical studies including infant clinical studies.
Adding BB-12® in infant formula represents a science-based approach to supporting infant gut health. This probiotic strain has been granted Generally Recognized as Safe (GRAS) status by regulatory authorities and has been safely consumed by millions of infants worldwide. Its extensive clinical documentation provides healthcare professionals with confidence when recommending formulas containing this specific probiotic strain to families seeking evidence-based nutritional options for their infants.
A review of randomized controlled trials conclude that the use of BB-12 in early infancy is safe and well-tolerated and does not result in adverse effects.12,13
Based on the available clinical evidence, BB-12™ is considered to be safe for infants and received GRAS (Generally Recognized as Safe) status since 2002 by the Food and Drug Administration (FDA) in the US for infants.14 In Europe, BB-12 has been granted Qualified Presumption of Safety (QPS) status since 2007 by the European Food Safety.15
The addition of the clinically studied probiotic strain BB-12® to infant formula represents a scientifically supported approach to supporting infant digestive health, immune development, and overall wellness. With over 300 scientific publications documenting its safety and efficacy, BB-12® stands as one of the most thoroughly researched probiotic strains available for pediatric nutrition. Its demonstrated benefits in supporting healthy gut microbiota composition, immune system maturation, digestive comfort, and intestinal barrier function make it a valuable component in modern infant formula formulations.
What is BB-12®?
BB-12® is the probiotic strain Bifidobacterium animalis subsp. lactis, one of the world's most extensively studied probiotics.
Is BB-12® safe for infants?
Yes. Randomized clinical trials have shown that BB-12® is safe and well tolerated in infants. It has also received GRAS status from the FDA and QPS status from EFSA.
What are the benefits of BB-12®?
Clinical studies have associated BB-12® with:
Improved digestive function
Better gut microbiota balance
Softer stools
Immune support
Fewer respiratory infections
Less crying
Longer sleep
Reduced eczema severity
Is BB-12® a probiotic or a prebiotic?
BB-12® is a probiotic, meaning it is a live beneficial bacterium. It differs from prebiotics, which are dietary fibers that nourish beneficial bacteria.
Does BB-12® support the gut microbiota?
Yes. BB-12® helps promote beneficial bacteria and contributes to the development of a balanced intestinal microbiota.
References:
1. Chen et al. 2021; 2. Vlieger et al. 2009; 3. Saavedra et al. 1994; 4. Weizman et al. 2005;
5. Rautava et al. 2009; 6. Taipale et al. 2011; 7. Taipale et al. 2016;
8. Nocerino et al. 2020; 9. Isolauri et al. 2000; 10. Schmidt et al. 2019; 11. Hill et al. 2014;
12. Szajewska et al. 2020; 13. Szajewska et al. 2013; 14. Vlieger et al. 2009; 15 FDA 2002;
16. EFSA 202