Effects of a Synbiotic Intervention on Perimenopausal/Menopausal Symptoms

NCT07759908 | Completed DMC

• 2 other identifiers: ECM 3 (ww) 15/05/2025CF20242330-I
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Perimenopause; Perimenopausal Women

Keywords

Perimenopause; Menopause; Microbiome; Brain health; Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  0-56 days

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Participants in the active arm to show a change from baseline in vaginal and gut microbiome.

  0-56 days

Study Arms (2)

Synbiotic arm

ACTIVE COMPARATOR

This arm will receive a capsule with the 4 probiotics and a sachet with the fibre to be consumed together

Dietary Supplement: Femmebiome Meno

Placebo

PLACEBO COMPARATOR

This arm will receive a placebo filled capsule as well as a placebo filled sachet

Dietary Supplement: Placebo

Interventions

Femmebiome Meno DIETARY_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.

Synbiotic arm

Placebo DIETARY_SUPPLEMENT

Placebo capsule and placebo sachet

Placebo

Eligibility Criteria

• Age: 44 Years - 55 Years
• Gender Eligibility Details: born female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants will be excluded from the study if they meet any of the following criteria:
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• 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)

Sponsors & Collaborators

• University College Cork: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Ireland

Location

Related Publications (3)

• 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.

  PMID: 31155270 RESULT

• Santoro 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.

  PMID: 33095879 RESULT

• Talaulikar 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.

  PMID: 35382992 RESULT

Related Links

• 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 rece

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Siobhain M O'Mahony, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: August 12, 2026
• Study Start: June 6, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

IE (1)