Could probiotics cool hot flashes? new trial investigates
NCT ID NCT06446869
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a daily probiotic supplement can help reduce menopause symptoms like hot flashes and night sweats, and improve quality of life. The trial will include 140 peri- or post-menopausal women who have frequent symptoms. Participants will take either the probiotic blend or a placebo for several weeks, and researchers will track changes using a standard symptom questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- probiotic blend (Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051, Pediococcus acidilactici KABP-021)
- What this could lead to
- If it works, this could offer a natural, non-hormonal option to reduce menopause symptoms like hot flashes and night sweats.
- What could go wrong
- This is an early-stage trial with only 140 participants, so results may not apply to all women. Probiotics are generally safe, but the effect on symptoms may be small or no better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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42 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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FutureMeds Glasgow
RECRUITINGGlasgow, Glasgow, G20 7BE, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- A phone game takes on menopause brain fog