Health Canada confirms ROSELLA can maintain a healthy vaginal microbiome
Lallemand Health Solutions’ convenient orally administered probiotic shown to support women’s intimate health, L. plantarum ROSELLA[1], has gained new indications from Health Canada, recognizing its capacity to help support a healthy vaginal microbiome.
More precisely the claims obtained are:
- Source of probiotics
- Helps support female or vaginal health
- Helps support a healthy vaginal microflora
- Maintains a healthy vaginal microbiome
“This unique probiotic strain, isolated from a healthy vaginal flora with full mechanistic and clinical evidence, is one of the most documented strains in the world in the women’s health area. It has been studied in over 800 women, in six clinical studies, including two by oral intake. Health Canada just confirmed the strain’s ability to support women’s intimate health while taken orally,” explained Solange Henoud, Global Regulatory Affairs Director at Lallemand Health Solutions. “Women will be enthusiastic to rely on such a natural solution with a convenient route of administration” she added. “On a separate note, it is important to notice how Canadian regulators are recognizing terms such as microbiome which at the end will also serve to enlighten consumers, through accurate labelling, on the most modern scientific language used in our field” she concluded.
Last year Lallemand Health Solutions acquired the right to license and commercialize Proge Farm®’s well established probiotic strain L. plantarum P17630 (Proge P17630®), which is recognized for its specific women health benefits on a wide spectrum of benefits, from helping to maintain proper vaginal balance, to being used for recurrent Vulvovaginal Candidiasis (rVVC).
ROSELLA is available in various convenient dosage forms and handy packaging and can be specially formulated with other carefully selected ingredients for extra health claims relevant to this specific targeted population[2].
You can read more about Women’s health and Rosella in our White Paper. Contact us for more information.
About ROSELLA: Her ally for a healthy intimate flora
ROSELLA is a highly documented strain in the Women’s health area and has shown impressive significant results in many studies:
- Studied on over 800 women: 6 clinical studies including 2 with oral treatment
- Helps promote vaginal health alone [Vladareanu 2018] or as an adjunct to conventional treatment (anti-fungal) in VVC or BV [Nava 2002, Carriero 2007, De Seta 2014, Cianci 2016]
- Demonstrated vaginal colonization and persistence following oral intake with a validated efficacy dose: 5B CFU/day [Montella 2013, 2014]
- Normalizes pH and restores flora diversity associated with a healthy vaginal flora
- Demonstrated adhesion to vaginal epithelial cells and interference with C. albicans (in vitro) [Culici 2004]
About Lallemand Health Solutions
From lab to shelf, Lallemand Health Solutions has the full control and expertise to produce premium probiotic solutions, blends, and custom formulations, as each development step is expertly supported by internal quality assurance, regulatory affairs, research and development, scientific affairs, technical support, and sales and marketing teams. EXPERT’Biotics are ready-to-market documented formulas supported by research and development from in vitro and in vivo models to clinical studies, with complete registration dossier and claims available, product training and communication tools. EXPERT’Biotics exist in several dosage forms with stability data and can be added to ROSELLA for added benefits.
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MEDIA CONTACT
Marilou Luneau, Content Manager, Lallemand Health Solutions, mluneau@lallemand.com
[1] L. plantarum ROSELLA is L. plantarum P17630 (Proge P17630®), licensed from PROGE FARM®, Italy.
[2] *Formulas composition and claims based on strains scientific data and according to local regulation
