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NCT07759908

Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms

Sponsor: University College Cork

View on ClinicalTrials.gov

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. 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.

Official title: Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

FEMALE

Age Range

44 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-06

Completion Date

2025-12-30

Last Updated

2026-08-12

Healthy Volunteers

Yes

Conditions

Menopause Perimenopause Perimenopausal Women

Interventions

DIETARY_SUPPLEMENT

Femmebiome Meno

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.

DIETARY_SUPPLEMENT

Placebo

Placebo capsule and placebo sachet

Inclusion Criteria: * To be eligible for inclusion, the Participant must fulfil all the following criteria: 1. Be able to give informed consent. 2. Be between 44 -55 years, inclusive. 3. Experiencing a score of \>4 on all of the symptoms below, within the past 12-months, measured by the MenQoL. 1. sleep disturbances 2. mood changes 3. changes in sexual function 4. Willing to consume the Study Product daily for the duration of the study. 5. Is in general good health, as determined by the investigator. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria:  1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding. 2. Has food allergies or other issues with foods that would preclude intake of the Study Products or any known severe allergies. 3. Is experiencing surgical menopause (bilateral oophorectomy before natural menopause occurs). 4. 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: 1. Uterine fibroids (current or previous 12 months) 2. Endometriosis (current or past history) 3. Polycystic ovarian syndrome (current or past history) 4. History of abnormal pap smear (current or previous 12 months) 5. Enema (in the past 12-weeks) 5. Planned invasive medical procedures 3-weeks prior to and for the duration of the study. 6. 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: 1. Antibiotics 2. Hormone replacement therapies (current or planned use) 3. Hormonal birth control (current or planned use) 4. Laxatives 7. Recent (in the past 12-weeks) initiation of supplements or herbal remedies commonly used to support perimenopause/menopause symptoms. 8. Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements, including: 1. Probiotics 2. Prebiotics 3. Postbiotics 4. Fibre supplements 9. Planned major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) during the duration of the study. 10. 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. 11. 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.

Locations (1)

Atlantia Clinical Trials

Cork, Ireland