Lallemand Health Solutions

 

 

Her ally for a healthy intimate flora

 

A convenient orally administered probiotic shown

to support women’s intimate health

 

Probiotics for women’s health

Over the past five years, the market for nutritional ingredients for women’s health carried on evolving to a more mature market, driven by consumers’ interest and research and development. With robust scientific backing and product development on the rise, global probiotic markets have been, in fact, growing fast for more than a decade. Lumina Intelligence confirms products have diversified from initial cores of gastro-intestinal health and immunity to a much broader range of benefits including skin, sports performance, brain health and more female-focused areas like vaginal health, urinary tract infections (UTIs), pregnancy and osteoporosis. Probiotics research and development is undeniably popular, with over 1600 ongoing human clinical trials on probiotics listed in clinicaltrial.gov and WHO’s trial database.

According to Grand View Research, the women’s health and beauty supplement market has reached $49.8 Billion in 2019 and the estimated compound annual growth rate (CAGR) for 2020- 2026 is 4.75%. The probiotics for women’s health core growth areas are: vaginal health, urinary tract infections, pregnancy and skin health. Among non-supplement women users, 40% of them think their « feminine health issues » could be improved by using supplements.

Probiotics for women’s health is a fast-growing market, increasingly attracting women through online and on-site retail places. Although women’s probiotic market used to be a niche market, it is now becoming a strong differentiation factor for product development, explaining why, since the past two years, a lot of new probiotic products target women, and consequently consumers online engagement is increasing: between December 2017 and January 2020 the number of reviews for women’s intimate health probiotics increased by 804%, on average from the 20 countries studied. Specific probiotics are gaining attraction as they are a natural alternative to the conventional over-the-counter solutions for vaginal health. Women are willing to try them out especially when vaginal health conditions are recurrent, which alters general quality of life.

Probiotics for women’s health is a major opportunity to expand brand portfolios with a potential target audience of over 1.4 billion women. Genito-urinary issues, including vulvovaginal candidiasis, urinary tract infections and bacterial vaginosis are the leading conditions, bringing women to seek out medical advices, prescriptive drugs and to investigate natural efficient complementary supplements, such as probiotics.

Lactobacilli: The gatekeepers of feminine health

The female vaginal microflora is a rich and complex ecosystem, mainly consisting of Lactobacilli which support the vaginal environment and health. During her lifespan, every woman encounters specific health and well-being issues according to her lifestyle, physiology, hormonal cycles and life stages. Vaginal balance is fragile, and many internal or external factors can affect this balance: gut health, immunity, mood balance, oral health, intimate health… they all have been linked by scientists to endogenous microbiota.

Life cycles of ovarian hormones

 

Acting upon the gut or vaginal microbiota, specific probiotics can help each individual woman at every stage of her life, from puberty to menopause. The benefits of probiotics to support women’s health are increasingly recognised, mainly due to their ability to maintain and restore digestive and vaginal microflora balance, with positive consequences on feminine health as well as on digestive health, occasional stress or natural defenses. As per most of the beneficial effects of probiotics, the benefits on intimate health are not homogeneous for all the probiotics but are strain specific.

WHAT IS THE DIFFERENCE BETWEEN BACTERIAL VAGINOSIS AND VAGINAL YEAST INFECTION?

Bacterial vaginosis
is defined as a vaginal dysbiosis characterized by a decrease in concentration of Lactobacilli in the vagina and an increase in concentration of anaerobic bacteria such as Gardnerella vaginalis, Atopobium vaginae, Mycoplasma hominis, Prevotella, Porphyromonas. It is the most common vaginal infection in women of childbearing age.

Vaginal yeast
infection is also due to an imbalance in the vaginal flora. In this condition, the problem is a fungus called Candida, such as Candida albicans, which incapacitates commensal bacteria. Candida albicans are also often found in the gastro- intestinal tract, as part of a commensal bacteria. Candida can co-exist normally in the vagina without any problem, and a proper Candida albicans balance is an indicator of healthy vaginal microbiota. However, it may cause trouble if it outnumbers other microorganisms. Three out of four women will have an imbalance with a Candida albicans prominent microflora at some point in their life.

HOW TO PROBIOTICS PROMOTE VAGINAL HEALTH, EVEN DURING TIMES OF OCCASIONAL BACTERIAL IMBALANCE

Lactobacilli can help rebalance the vaginal microflora and promote vaginal comfort during times of occasional vaginal imbalance. Lactobacilli probiotics, which have a positive effect on endogenous microflora could thus help support the vaginal microflora and protect against some undesirable bacteria.

Meet women’s new best friend: ROSELLA

To recolonize the vaginal microflora zone, choosing the right bacteria strain is crucial.

Moreover, only a handful of probiotic supplements taken orally can do the trick. L. plantarum P17630 (Proge 17630®), ROSELLA, is one of them.

  1. plantarum P17630 (Proge 17630®), ROSELLA is a unique strain isolated from a healthy vaginal flora with full mechanistic and clinical evidence of efficacy on a wide spectrum of benefits, from helping to maintain proper vaginal balance, including from oral intake, to being used for recurrent Vulvovaginal Candidiasis (rVVC). This probiotic strain is one of the most documented in the world in the women’s health area, as it has been studied in over 800 women, in six clinical studies, including two by oral intake. In combination or not with conventional treatments for candidiasis (anti-fungal) women saw an improvement in candidiasis with a decrease in symptoms including less swelling, redness, burning or itching infection that can be caused by an overgrowth of bad bacteria. This probiotic strain also helped reduce the risk of recurrence of this candidiasis*.

ROSELLA is scientifically backed by mechanistic data. Studies showed this specific strain was able to
adhere and interfere with C. albicans (in vitro studies). It demonstrated vaginal colonization and persistence following oral intake (validated efficacy dose: 5B CFU/day). ROSELLA restores flora diversity associated with a healthy vaginal flora and promotes vaginal diversity associated with a healthy vaginal microbiota by normalizing pH. Furthermore, there are clinical evidences that this unique strain helps promote continued vaginal health in Vulvovaginal Candidiasis and in recurrent Vulvovaginal Candidiasis as adjunctive treatment with triazole or alone.

HOW CAN ORAL PROBIOTICS, AFTER PASSAGE THROUGH THE GUT, HAVE A BENEFICIAL
IMPACT ON THE VAGINAL MICROFLORA?

Probiotics taken orally will pass through the gut, colonize the intestine and will be excreted in faeces. Anatomically, anus and vagina are very close, so naturally bacteria will pass and arrive in vagina in order to colonize it. This natural phenomenon occurs with “bad” bacteria causing infections like bacterial vaginosis, but also with “good” bacteria like probiotics. Gut to vagina passage was confirmed by clinical studies, in particular with ROSELLA which is found in vagina after oral intake. In Montella study, ROSELLA also showed persistence as ROSELLA was not only found in vagina after oral intake, but also after a 15 days wash-out period.

Colonization of the vaginal microflora and Persistence study in healthy women
[Montella, 2013 and 2014]

On 24 healthy women with a normal vaginal flora, an optimal oral intake dose was determined of 5B CFU/day with two cycles of 15 days intake followed by 15 days washout among different dose and regimen. ROSELLA strain was identified by Polymerase Chain Reaction (PCR) with specific strain primers in both faecal and vaginal samples, even after a 15 days washout period, demonstrating the gut to vagina passage, colonization and persistence.

Efficacy study in healthy women prone to experiencing temporary imbalances in their vaginal microflora [Vladareanu, 2018]

Following the Montella pilot study confirming dose and safety, an efficacy study was conducted on 93 healthy women with recurrent vulvovaginal candidiasis enrolled during relapse-free period. These women took either ROSELLA (5B CFU/day) or a placebo during three cycles of 15 days, followed by 15 days washout. At T0, around 60% of women have an abnormal vaginal flora (LBG IIa to LBG III). In the ROSELLA group, there was a significant increase (p<0.0001), nearly the double of participants, with a normal flora (LBGI) after the first follow up at 45 days. There was also a maintenance of the normal flora after 90 days. As per the placebo group, there were no vulvovaginal candidiasis improvement.

LBG score percentage

 

Changes in clinical signs during treatment

 

In the same study, there was a reduction of the intensity of signs and symptoms associated with vulvovaginal candidiasis in the ROSELLA group. The changes in clinical signs during treatment showed a significant decrease of vaginal mucosa redness and in swelling intensity in comparison to the placebo group after 45 days. These results were persistent after 90 days.

Values of symptoms average in patients with relapsing candidasis

 

Vaginal intake proof of efficacy: Reduction of pH, symptoms and recurrences

In 2002, two Nava pilot studies on bacterial vaginosis and vulvovaginal candidiasis with ROSELLA vaginal intake (0.1B CFU/day), a significant reduction of symptoms was observed after intake period and also maintenance, after the follow-up period, when compared to baseline. There was also a significant reduction of the pH, which is an indicator of a balanced and healthy vaginal flora.

In 2007, Carriero conducted a large placebo-controlled study on 476 women with vulvovaginal candidiasis, with a pre-intake of anti-fungal in order to confirm pilot study results. With a significant vaginal pH normalization, significant reduction of symptoms, significant reduction of relapses and maintenance after four months, ROSELLA efficacy was confirmed.

In 2014, De Seta study results on pH normalization, increase of lactobacilli and improvement of symptoms, ROSELLA’S legitimacy was equally confirmed.

In 2016, Cianci, in order to open indications, ROSELLA was tested in a pilot study on 94 women with bacterial vaginosis (BV) and aerobic vaginitis (AV). After 15 days, a significant increase of reported clinical resolution was observed.

WHY MAINTAINING VAGINAL PH BALANCE IS ESSENTIAL TO KEEPING A HEALTHY VAGINAL FLORA?

The pH scale runs from 0 to 14. A pH of less than 7 is considered acidic, and a pH of more than 7 is basic. A normal vaginal pH level is between 3.8 and 4.5, which is moderately acidic. However, what constitutes a “normal” pH level can vary slightly during a women’s life due to internal changes, and many external factors can also modify the pH levels in this delicate zone. Whilst an acidic vaginal environment is protective and creates a barrier that prevents unhealthy bacteria and yeast from multiplying too quickly and causing infection, weak acid, or raised pH levels provides the perfect setting for unhealthy bacteria to develop, hence putting women at risk of contracting various more or less severe infections.

 

 

LALLEMAND HEALTH SOLUTIONS
Quality probiotics. Complete solutions.

 

Contact Lallemand Health Solutions for more details. HealthSolutions@Lallemand.com or visit https://lallemand-health-solutions.com/ en/rosella/

 

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.