Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Participants in the active arm to show a change from baseline score on the Menopause-Specific Quality of Life questionnaire.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 44 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible for inclusion, the Participant must fulfil all the following criteria:
- •Be able to give informed consent.
- •Be between 44 -55 years, inclusive.
- •Experiencing a score of >4 on all of the symptoms below, within the past 12-months, measured by the MenQoL.
- •sleep disturbances
- •mood changes
- •changes in sexual function
- •Willing to consume the Study Product daily for the duration of the study.
- •Is in general good health, as determined by the investigator.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- •Has food allergies or other issues with foods that would preclude intake of the Study Products or any known severe allergies.
- •Is experiencing surgical menopause (bilateral oophorectomy before natural menopause occurs).
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
- •Uterine fibroids (current or previous 12 months)
- •Endometriosis (current or past history)
- •Polycystic ovarian syndrome (current or past history)
- •History of abnormal pap smear (current or previous 12 months)
- •Enema (in the past 12-weeks)
- •Planned invasive medical procedures 3-weeks prior to and for the duration of the study.
- •Current or recent (in the past 4-weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- •Antibiotics
- •Hormone replacement therapies (current or planned use)
- •Hormonal birth control (current or planned use)
- •Recent (in the past 12-weeks) initiation of supplements or herbal remedies commonly used to support perimenopause/menopause symptoms.
- •Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements, including:
- •Postbiotics
- •Fibre supplements
- •Planned major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) during the duration of the study.
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
研究组 & 干预措施
Synbiotic arm
This arm will receive a capsule with the 4 probiotics and a sachet with the fibre to be consumed together
干预措施: Femmebiome Meno (Dietary Supplement)
Placebo
This arm will receive a placebo filled capsule as well as a placebo filled sachet
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Participants in the active arm to show a change from baseline score on the Menopause-Specific Quality of Life questionnaire.
时间窗: 0-56 days
The MenoQoL questionnaire will be used to measure menopause specific symptoms at 0, 4, 8 weeks.
次要结局
- Participants in the active arm to show a change in vaginal pH compared to baseline.(0-56 days)
- Participants in the active arm to show a change from baseline in mental health.(0-56 days)
- Participants in the active arm to show a change from baseline in sleep behaviour.(0-56 days)
研究者
Siobhan O'Mahony
Professor
University College Cork