Lallemand Health Solutions Secures New Canadian Health Claims for Prenatis Probiotic

Lallemand Health Solutions has announced that its probiotic formulation Prenatis has received new approved health claims from Health Canada, expanding the scientific and regulatory positioning of the ingredient for maternal and infant health applications. According to the company, the newly authorized claims include support for vaginal health and healthy vaginal flora in mothers, as well as support for a healthy gut flora in newborns when mothers supplement during breastfeeding, a press release from Lallemand explained.¹

Prenatis Formula

The formula combines two probiotic strains—Lactobacillus rhamnosus Rosell-11 and Bifidobacterium bifidum HA-132—and was developed to support women during pregnancy while also promoting the establishment of a beneficial infant microbiome in early life. The ingredient can be formulated as a standalone probiotic, the company added, or combined with other strains and nutrients such as vitamin B9 (folic acid) for prenatal formulations.

Prenatis is available in multiple delivery formats—including sachets, sticks, capsules, and orodispersible powders—providing flexibility for dietary supplement manufacturers developing products for expectant and new mothers.

Clinical Research Results on Prenatis

Solange Henoud, Vice President of Regulatory and Compliance at Lallemand Health Solutions, said the approval underscores the company’s commitment to women’s health research. “These new health claims provide evidence of our serious commitment to women’s health and validate years of research and innovation that aimed at supporting female health during pregnancy and demonstrating the power of breastfeeding in transmitting mother to baby benefits,” she stated. “The Prenatis blend has proven the establishment of a healthy foundation for the breastfed babies’ microflora, in addition to the benefits for the moms. We are very proud to offer a scientifically backed solution meeting high regulatory standards for such a vulnerable population.”

As the press release explains, Prenatis has been evaluated in a clinical trial, published in Nutrients in 2025, involving 180 healthy pregnant women in their third trimester and their infants.² As the study explains, changes in the oral, gut, and vaginal microbiome occur during pregnancy, making women more vulnerable to various infections. Additionally, the infant’s gut microbiome is influenced by microbes transferred from the mother’s microbiomes. Supplementation with probiotics have been shown to improve vaginal health and offer immunological benefits in pregnant women, it adds, suggesting this could also provide support the health of the infant through beneficial microbial exposure.

Participants consumed 5 billion CFU of the probiotic blend daily for 12 weeks prior to birth and continued supplementation for four to six weeks postpartum. Follow-up assessments extended up to one year after delivery.

Results from the study showed that mothers taking the probiotic experienced fewer diagnosed infections and a trend toward reduced bacterial vaginosis. In infants, supplementation was associated with fewer sick days and improved development of gut microbiota during the first months of life. Researchers also observed enhanced colonization of beneficial bacteria in exclusively breastfed infants, with particularly notable microbiome benefits seen among babies delivered by cesarean section. “Since they lack exposure to the mother’s vaginal microbiota and may require additional support to initiate healthy microbiome establishment, infants born by C-section may benefit from probiotic intake in mothers during pregnancy and lactation to a larger extent than infants born vaginally,” the researchers noted.

Élodie Aragon, product manager at Lallemand Health Solutions, said the findings highlight new opportunities for brands developing targeted solutions for pregnant women.

This article was created with assistance from AI. The content has been reviewed and edited by Erin McEvoy, Associate Editor. For more information on the extent and nature of AI usage, please contact us.

References

1. Lallemand. Prenatis by Lallemand Obtains New Canadian Health Claims. Published December 1, 2025. Accessed March 13, 2026. https://www.lallemand-health-solutions.com/en/news-trends/press-releases/prenatis-by-lallemand-obtains-new-canadian-health-claims/
2. Binda S, Chow-Shi-Yée M, El Salti S, et al. The Effect of Probiotics on Health in Pregnancy and Infants: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2025; 17(11):1825. doi:10.3390/nu17111825