Probiotic to reduce menopausal symptoms
Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women
This trial will test whether a probiotic blend can boost recycling of active estrogens and reduce hot flashes and night sweats in perimenopausal and early postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 42 Years to 60 Years |
| Sex | Female |
| Sponsor | Community Pharmacology Services Ltd Academic / other |
| Locations | 1 site (Glasgow, Glasgow) |
| Trial ID | NCT06446869 on ClinicalTrials.gov |
What this trial studies
This interventional study gives eligible perimenopausal or early postmenopausal women either an active probiotic product (Gyntima Menopause) or a placebo to see if the probiotic increases recirculation of active estrogens and eases menopausal symptoms. Eligible participants must have frequent vasomotor symptoms (≥5 hot flashes/night sweats per day or ≥35 per week recorded over 14 days), a Menopause Rating Scale II score ≥9, and BMI 18.5–34.9 kg/m2. Women with surgical menopause, recent hormone therapy, certain hormone-sensitive cancers, or recent use of specific supplements are excluded. Study procedures include daily symptom recording and in-clinic visits at the single listed site in Glasgow.
Who should consider this trial
Good fit: Perimenopausal or postmenopausal women with spontaneous menopause and amenorrhoea under 2 years who have frequent hot flashes/night sweats (≥5/day or ≥35/week), an MRS‑II total score ≥9, and BMI between 18.5 and 34.9 kg/m2.
Not a fit: Women with surgical menopause, a history of hormone-sensitive cancers, recent use of hormone therapy or certain supplements, or those outside the symptom/BMI criteria are unlikely to qualify or benefit from this intervention.
Why it matters
Potential benefit: If effective, this could provide a non-hormonal, oral option to reduce hot flashes and night sweats for some women.
How similar studies have performed: Modifying the gut microbiome to influence estrogen metabolism is an emerging idea with some early supportive data, but probiotics specifically to treat menopausal vasomotor symptoms have limited direct evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoea for less than 2 years * Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35 or more per week recorded daily for 14 consecutive days) * BMI between 18.5 and 34.9 kg/m2 * Menopause rating score II (MRS-II) total score of 9 or more at baseline visit * Willing to sign Informed Consent Form * Willing to not make relevant changes to their current dietary or lifestyle habits during study * Able to follow study procedures * If perimenopausal, agrees to use an accepted method of contraception for duration of study. Exclusion Criteria: * History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or cancers associated with sex hormones * Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months prior to the start of the study * Intake of herbal or food supplements with known effects on menopause symptoms within 1 month prior to the start of the study. Examples of prohibited substances are black cohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop \[Humulus lupulus L.\], soy isoflavones, red clover) within 1 month prior to the start of the study * Use of any food supplement containing probiotics or postbiotics or regular consumption (\>3 days/week) of foods containing probiotics (including yogurt with added probiotics or bifidus effect) within 1 month prior to the start of the study * Use of oral (\>3 days) or parenteral antibiotics within 1 month prior to the start of the study * Participants with a new diagnosis of mental health disorder in the last 12 months or with an unstable or uncontrolled mental health disorder in the opinion of the Investigator * Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus * Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome * History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreated or unstable * History of gastrointestinal surgery 6 months prior to the start of the study, with the exception of appendicectomy * Regular intake (\>3 days/week) of medication that affects microbiota or bowel movements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate) * History of coronary disease, myocardial infarction, unstable angina, or previous coronary angioplasty * History of venous thromboembolism (VTE) or known to be high risk for VTE due to inherited or acquired thrombophilia (such as factor V Leiden, antiphospholipid syndrome) * History of stroke or transient ischaemic attack * History of severe renal dysfunction as defined by an estimated glomerular filtration rate \<30 mL/minute or severe liver dysfunction defined as established cirrhosis or active liver disease with alanine aminotransferase (ALT) \>3 × upper limit of normal at baseline * Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or nutraceuticals for a medical condition that can affect study outcomes according to the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90 days prior to study entry * Diagnosis of primary or secondary immunodeficiency including acquired immunodeficiency syndrome, immunodeficiency, or active oncologic disease * Known or suspected alcohol or drug abuse * Any other surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study * Currently participating in another study or having participated in one within 3 months prior to the start of the study * The participant is pregnant, planning a pregnancy, or breastfeeding
Where this trial is running
Glasgow, Glasgow
- FutureMeds Glasgow — Glasgow, Glasgow, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kristen Laing, MBChB — Community Pharmacology Services Ltd
- Study coordinator: Kristen Laing, MBChB
- Email: kristen.laing@futuremeds.com
- Phone: 0141 946 7888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.