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Menopausal Symptoms Probiotic Study

Sponsor: Community Pharmacology Services Ltd

NCT ID: NCT06446869

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Gyntima Menopause (supplement), Placebo (other)
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
Gyntima Menopause — supplement: Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021 · Placebo — other: Placebo comparator
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
42 Years to 60 Years
Who
Female
Number of participants
140
Started
2024-09-10
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for menopause
  • • NA - 140 participants
  • • In this study, we want to investigate if the active product consisting of a probiotic blend can potentiate the recirculation of active oestrogens into the bloodstream and help to mitigate menopause symptoms, which are closely related to oestrogens levels

Who can take part?

  • • Ages 42 Years to 60 Years
  • • Diagnosed with menopause
  • • Female only

Where?

  • • Glasgow - FutureMeds Glasgow

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

In this study, we want to investigate if the active product consisting of a probiotic blend can potentiate the recirculation of active oestrogens into the bloodstream and help to mitigate menopause symptoms, which are closely related to oestrogens levels

Menopause

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 42 Years - 60 Years
  • Who can join: Female only

What the study is looking for

  • ✓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...
  • ✓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 agreement to take part Form

Who cannot take part

  • ✗History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or...
  • ✗Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months prior to the start of...
  • ✗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...
  • ✗Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus
See the full 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 Is This Study? (1 UK site)

FutureMeds Glasgow

Glasgow G20 7BE, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Kristen Laing, MBChB

Sponsor contact

CONTACT

0141 946 7888 kristen.laing@futuremeds.com

David Cogan

Sponsor contact

CONTACT

0141 946 7888 david.cogan@futuremeds.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01