Addressing the women’s health gap – the 25% more time that women spend in ‘poor health’ relative to men – could not only increase women’s health span, but boost the global economy by US$1 trillion annually by 2040, according to McKinsey & Co.¹
This comes down to not only sex-specific conditions, but also general health conditions that affect women differently or disproportionately. In many cases, there has been too little research conducted in female populations for many health conditions because of the hormonal fluctuations from menarche to menopause.
Jordi Riera, Chief Business Officer at Kaneka Probiotics, notes the company has placed women’s health at the forefront of its innovation strategy. “Recognizing the persistent gaps in women’s health research and solutions, we are committed to bridging these gaps by advancing next-generation probiotics that support women throughout every stage of life: from adolescence through post menopause,” he says.
“Our clinically studied strains are developed to target key physiological needs unique to women, including vaginal and urinary tract health, hormonal support, digestive wellness, immune support, cognition, and skin support. These solutions are grounded in human clinical evidence, microbiome science, and a deep understanding of the female life cycle.”
This dovetails with the continued investigation and interest in the role of the microbiome on every aspect of human health – including its impact on hormones. Some of the most interesting work in this area revolves around the estrobolome.
This refers to the genes within the gut bacteria that are responsible for metabolizing estrogen; by deconjugating estrogen into free, active forms, it directly regulates circulating estrogen levels. Estrogen levels not only impact reproduction, but systems including bone strength, cognitive function and mood regulation, cardiovascular wellness, and skin hydration.
Dysbiosis of the estrobolome can lead to excess recirculation of estrogen or its premature elimination, both of which can contribute to hormone imbalance, particularly during perimenopause and post menopause. According to literature, approximately 80% of conjugated estrogens are reactivated and reabsorbed in the gut.² This suggests 20% of total estrogen could be modulated via microbial activity, potentially offering a path for unique product solutions.
Awareness of menopausal symptoms and their long-term health implications is growing fast. And as it is estimated there will be 1.2 billion menopausal women by 2030, it is not surprising that there is a drive to create unique products to support women in managing over 50 symptoms associated with menopause.
Previous market assessments examining probiotic products with an impact on menopause showed steady increases in new product development from 2017 into 2023; current tracking through Amazon suggests the number has increased incrementally since that point with more than 100 companies offering targeted products in this category.
Investigating the impact in female populations
However, this also comes with awareness that there needs to be more scientific research to understand how specific probiotic strains can specifically support a healthy estrobolome. Preclinical research has shown that certain gut bacteria in the estrobolome, characterized by glucuronidase activity (GUS+), secrete an enzyme known as beta-glucuronidase.
This enzyme can help deconjugate estrogens, yielding higher levels of circulating estrone and estradiol. With this foundational insight, Kaneka Probiotics tapped into its library of human-residential strains with identified phenotypic characteristics. L. brevis KABP®-052 strain was selected for its ability to modulate the estrobolome through GUS+ activity, supporting the reactivation of endogenous estrogens. Preclinical work found that after one hour of incubation, L. brevis KABP 052 produced significantly higher levels of deconjugated estrogens than other strains.
From this initial insight, the team instigated a 12-week randomized, double-blind, placebo-controlled clinical trial.³ Conducted at two clinical centers under the control of a contract research organization, 111 healthy peri- and postmenopausal women received one capsule/day of placebo or a probiotic blend with >1 billion CFU.
The blend contained not only L. brevis KAPB®-052, but L. plantarum KABP®-051 and Pediococcus acidilactici KABP®-021 to help inhibit opportunistic pathogens, in a ratio of 2:1:1 CFU, respectively. During the study period, estrogen concentrations were analyzed according to age and estrogen level (E1 and E2) at baseline.
At the end of the intervention, the probiotic group had significantly higher levels of circulating estradiol and estrone compared to the placebo group, when adjusting for baseline estrogen concentrations and age. In addition, estrogen levels in the probiotic group were maintained over time, whereas those receiving the placebo had a significant decrease.
There was no difference in GUS activity in fecal samples at the conclusion of the study, nor significant differences in menopausal symptoms between the groups. This is the first direct link between targeted microbiome modulation of the estrobolome and estrogen balance in women, especially during the normal hormonal decline associated with aging, according to Riera.
“While this study was a breakthrough in the field, it builds on nearly a decade of Kaneka Probiotics’ work in women’s health,” says Riera. “Our clinically studied strains are developed to target key physiological needs unique to women, including vaginal and urinary tract health, hormonal support, digestive wellness, immune support, cognition, and skin support.
“These solutions are grounded in human clinical evidence, microbiome science, and a deep understanding of the female life cycle.”
There are currently four ongoing double-blind, placebo-controlled clinical trials in progress examining the impact of Kaneka’s solutions including KABP® Urinary Tract Support to address urogenital microbiota balance; KABP® Vaginal Health Balance for vaginal colonization; and KABP® Menopause.
Foundation of precision probiotics
KABP® Menopause is only the most recent example of Kaneka’s ability to bring precision probiotics to market that are selected and validated for specific mechanisms of action that lead to clinically meaningful health benefits. The company maintains a bank of more than 1,000 wild-type strains, many of which are patented, that were sourced in non-industrialized regions where microbial diversity is close to what humans evolved with.
From this point, Kaneka can identify and characterize a strain’s mechanisms of action – such as immune signalling, gut barrier integrity, or hormone modulation – and then develop formulations to target specific health outcomes.
“By combining targeted strain selection with ecological diversity and rigorous clinical validation, we are able to deliver next-generation probiotic solutions that are effective, focused, and designed to support specific health needs – particularly those of women – across the lifespan,” Riera says.
“Recognizing the persistent gaps in women’s health research and solutions, we are committed to bridging these gaps by advancing next-generation probiotics that support women throughout every stage of life, from adolescence through post menopause.”
References:
- McKinsey Health Institute. Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies.
- Barnes, R.B.; et al. CHAPTER 53 - Pharmacology of Estrogens. Treatment of the Postmenopausal Woman (Third Edition). Academic Press; 2007, Pages 767-777.
- Honda, S.; et al. Supplementation with a Probiotic Formula Having β-Glucuronidase Activity Modulates Serum Estrogen Levels in Healthy Peri- and Postmenopausal Women. Journal of Medicinal Food. Vol. 27, No. 8.
