An interventional study of Femmebiome Meno and Placebo in Menopause, Perimenopause and Perimenopausal Women, sponsored by University College Cork. Completed at 1 site in Ireland. Open to female participants aged 44 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University College Cork · Not applicable, Interventional, and Treatment
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 49 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for inclusion, the Participant must fulfil all the following criteria:
Experiencing a score of >4 on all of the symptoms below, within the past 12-months, measured by the MenQoL.
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
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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:
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:
Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive a capsule with the 4 probiotics and a sachet with the fibre to be consumed together
Dietary Supplement: Femmebiome Meno
This arm will receive a placebo filled capsule as well as a placebo filled sachet
Dietary Supplement: Placebo
FemmeBiome Meno is a proprietary blend of carefully selected probiotics and a targeted prebiotic, specifically designed to address the unmet health needs of women in the perimenopausal and menopausal stages of life. Developed by experts in women's health and microbiome science, this synbiotic formula supports the unique physiological changes women experience during this transition. The probiotic strains in FemmeBiome Meno have been chosen based on scientific evidence. FemmeBiome Meno is a natural, non-hormonal solution developed to meet the growing demand for safe, effective, and science-backed support for women navigating this important life stage.
Placebo capsule and placebo sachet
Participants in the active arm to show a change from baseline score on the Menopause-Specific Quality of Life questionnaire.
The MenoQoL questionnaire will be used to measure menopause specific symptoms at 0, 4, 8 weeks.
Time frame: 0-56 days
Participants in the active arm to show a change in vaginal pH compared to baseline.
Change from Baseline in Vaginal pH on a self-administered pH strip at 8 Weeks.
Time frame: 0-56 days
Participants in the active arm to show a change from baseline in mental health.
Change from Baseline in DASS-21 score at 4 and 8 Weeks.
Time frame: 0-56 days
Participants in the active arm to show a change from baseline in sleep behaviour.
Change from Baseline in sleep behaviour on the LSEQ at 4 and 8 weeks.
Time frame: 0-56 days
Participants in the active arm to show a change from baseline in vaginal and gut microbiome.
Change from Baseline in vaginal and gut microbiome using 16S sequencing at 8 weeks.
Time frame: 0-56 days
Plan to share: Undecided
Ran from Jun 2025 to primary completion in Sep 2025, 3 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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