Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms

Menopause, Perimenopausal Women, Perimenopause

Perimenopause, Menopause, Microbiome, Brain health, Anxiety, Stress

FemmeBiome Meno is a synbiotic supplement, meaning it contains both probiotics (beneficial bacteria) and prebiotics (a special kind of fiber that feeds these bacteria). It is made up of: One capsule with 4 carefully selected bacterial strains and one sachet of powdered fiber. Both the capsule and the fiber sachet are taken daily. There are also placebo versions (lookalike products with no active ingredients) for use in the clinical trial. This specific combination of bacteria and fiber has not been studied before. However, previous research on the individual bacterial strains has shown several promising effects, such as: Reducing inflammation in lab tests on vaginal cells. Lowering stress-related hormones. Supporting general feelings of well-being. Helping maintain a healthy gut barrier, which is crucial for immune and digestive health. The fiber helps nourish both the added bacteria and the helpful microbes already present in the body. Some of these bacteria are believed to be reduced during menopause, especially those involved in estrogen metabolism. Why This Study Matters The aim of this study is to see whether FemmeBiome Meno can ease some of the most common and disruptive symptoms of perimenopause and menopause. In a survey of over 100 women, the top concerns were: Poor sleep Anxiety Brain fog (difficulty thinking clearly) The study also aims to examine how the supplement affects gut and vaginal health, which are both influenced by the drop in reproductive hormones during this stage of life. With so many women affected and such limited options currently available, there is a clear and urgent need for effective, science-backed natural solutions. The FemmeBiome Meno study hopes to fill that gap by providing a validated product that can genuinely support women's health during midlife and beyond.

Menopause affects every person born female and by the year 2025 the number of post-menopausal women worldwide is estimated to reach 1.1bn. Yet, the number of women experiencing peri/menopause-like symptoms is likely to be much higher as women in the late-reproductive stage experience multiple symptoms often years before the official menopause transition. Because of increasing life expectancy women now spend up to 40% of their lives in perimenopause and menopause. Symptoms affect more than 85% of women with 25% of these describing their symptoms as severe. In a survey carried out by The Menopause Hub 61% of women said that menopause negatively impacted their relationship with their significant other and 84% said their work performance was negatively impacted. One third of women had considered giving up work due to symptoms. A recent Mayo Clinic study estimated that menopause costs American women $1.8 billion in lost working time per year. The WHO have identified a major gender health gap with Women's Health not being prioritised. Women's health is chronically under-addressed by scientifically supported clinical and nutritional options today. There are several pharmaceutical options for peri/menopausal women, including hormone replacement therapy (HRT). HRT can be extremely effective in reducing some of the symptoms of hormonal fluctuations. Many women however wish to explore natural alternatives. Furthermore, women with history of blood clots, breast cancer and other risk factors may opt not to take HRT to avoid further risk. Despite the strong consumer demand for natural solutions to support women during perimenopause and menopause, there is a lack of scientifically and clinically validated, dietary supplements to support women during these stages of life. Hence, the FemmeBiome Meno project aims to develop and clinically validate a synbiotic supplement that works for women to address this demand and exploit a very large and growing market opportunity. Study Product FemmeBiome Meno is a proprietary blend of 4 bacteria (capsule) and 1 fibre (sachet). There is a placebo equivalent capsule and sachet. Both capsule and a sachet of fibre are to be consumed daily during the trial. Potential mechanisms of action include reintroducing strains that are reduced during this stage of life associated with oestrogen metabolism as well as providing fibre to support this particular community of bacteria as well as the residing beneficial microbes. The combination of these 4 strains has not been assessed previously as well as the inclusion of this fibre. Previous studies have shown that these bacteria alone can reduce inflammatory insults on a vaginal cell line, reduce stress-related hormones, improve well-being, and have positive effects on gut barrier function. Rationale for conducting the study This study seeks to determine if a synbiotic supplement can support some of the symptoms noted to be most troublesome for women. A survey of over 100 women identified sleep, anxiety, and brain fog were the most prevalent and worrisome symptoms experienced. This supplement also aims to improve gut and vaginal health as these are also impacted due to decreases in reproductive hormones.

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