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Could probiotics cool hot flashes? new trial investigates

NCT ID NCT06446869

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

42 to 60 years

Sex

Female participants only

Healthy volunteers

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

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.

Hot Flashes

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • FutureMeds Glasgow

    RECRUITING

    Glasgow, Glasgow, G20 7BE, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.