MenopauseNCT07759908
Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms
A study testing Femmebiome Meno in people with Menopause and Perimenopause, run by University College Cork at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 44 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopause, Perimenopausal Women
- What is being tested?
- Femmebiome Meno
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteIreland
- Study dates
- 6 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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)
- Laxatives
- 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:
- Probiotics
- Prebiotics
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Menopause, Perimenopause, Perimenopausal Women
- Being tested
- Femmebiome Meno, Placebo
- Keywords
- Perimenopause, Menopause, Microbiome, Brain health, Anxiety, Stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femmebiome MenoDietary supplement
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.
PlaceboDietary supplement
Placebo capsule and placebo sachet
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic arm | Active comparator | This arm will receive a capsule with the 4 probiotics and a sachet with the fibre to be consumed together Receives: Dietary Supplement: Femmebiome Meno |
| Placebo | Placebo comparator | This arm will receive a placebo filled capsule as well as a placebo filled sachet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-56 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 0-56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start6 Jun 2025
- Primary completion30 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Principal investigator, Siobhan O'Mahony, University College Cork
- Investigators
- Siobhain M O'Mahony, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759908
- Sponsor's protocol ID
- ECM 3 (ww) 15/05/2025
- Other IDs
- CF20242330-I
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hay K, McDougal L, Percival V, Henry S, Klugman J, Wurie H, Raven J, Shabalala F, Fielding-Miller R, Dey A, Dehingia N, Morgan R, Atmavilas Y, Saggurti N, Yore J, Blokhina E, Huque R, Barasa E, Bhan N, Kharel C, Silverman JG, Raj A; Gender Equality, Norms, and Health Steering Committee. Disrupting gender norms in health systems: making the case for change. Lancet. 2019 Jun 22;393(10190):2535-2549. doi: 10.1016/S0140-6736(19)30648-8. Epub 2019 May 30.
PubMed 31155270Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764.
PubMed 33095879Talaulikar V. Menopause transition: Physiology and symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:3-7. doi: 10.1016/j.bpobgyn.2022.03.003. Epub 2022 Mar 16.
PubMed 35382992
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07759908
- Acronym / sponsor ID
- ECM 3 (ww) 15/05/2025
- Conditions
- Menopause, Perimenopause, Perimenopausal Women
- Keywords
- Perimenopause, Menopause, Microbiome, Brain health, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic arm | Active comparator | Dietary Supplement: Femmebiome MenoThis arm will receive a capsule with the 4 probiotics and a sachet with the fibre to be consumed together |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will receive a placebo filled capsule as well as a placebo filled sachet |
Who may qualify
- Ages
- 44 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- To be eligible for inclusion, the Participant must fulfil all the following criteria:
Key exclusion criteria (26 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femmebiome MenoFemmeBiome 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. | Dietary supplement | Synbiotic arm |
| PlaceboPlacebo capsule and placebo sachet | Dietary supplement | Placebo |
Primary outcome
Participants in the active arm to show a change from baseline score on the Menopause-Specific Quality of Life questionnaire.
Time frame: 0-56 days
The MenoQoL questionnaire will be used to measure menopause specific symptoms at 0, 4, 8 weeks.
3 secondary outcomes
Participants in the active arm to show a change in vaginal pH compared to baseline.
Time frame: 0-56 days
Participants in the active arm to show a change from baseline in mental health.
Time frame: 0-56 days
Participants in the active arm to show a change from baseline in sleep behaviour.
Time frame: 0-56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publication: PubMed 31155270Hay K, McDougal L, Percival V, Henry S, Klugman J, Wurie H, Raven J, Shabalala F, Fielding-Miller R, Dey A, Dehingia N, Morgan R, Atmavilas Y, Saggurti N, Yore J, Blokhina E, Huque R, Barasa E, Bhan N, Kharel C, Silverman JG, Raj A; Gender Equality, Norms, and Health Steering Committee. Disrupting gender norms in health systems: making the case for change. Lancet. 2019 Jun 22;393(10190):2535-2549. doi: 10.1016/S0140-6736(19)30648-8. Epub 2019 May 30.
- Results publication: PubMed 33095879Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764.
- Results publication: PubMed 35382992Talaulikar V. Menopause transition: Physiology and symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:3-7. doi: 10.1016/j.bpobgyn.2022.03.003. Epub 2022 Mar 16.
- The aim of this study is to investigate the effects of the supplement on perimenopausal/menopausal symptoms over an 8-week period. The supplement is a blend of 4 bacteria and a fibre. Participants in the study will be randomly assigned to either receLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhain M O'Mahony, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femmebiome Meno in people with Menopause and Perimenopause, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants in the active arm to show a change from baseline score on the Menopause-Specific Quality of Life questionnaire. (time frame: 0-56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759908, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.