Menopausal Symptoms Probiotic Study

Last updated: January 23, 2026
Sponsor: Community Pharmacology Services Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Menopause

Treatment

Placebo

Gyntima Menopause

Clinical Study ID

NCT06446869
KNK-DONACARE
  • Ages 42-60
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoeafor less than 2 years

  • Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35or 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 habitsduring study

  • Able to follow study procedures

  • If perimenopausal, agrees to use an accepted method of contraception for duration ofstudy.

Exclusion

Exclusion Criteria:

  • History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine orendometrial cancer, breast cancer, or cancers associated with sex hormones

  • Use of hormonal replacement therapy, hormone analogues, or oral contraceptiveswithin 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 blackcohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop [Humulus lupulusL.], soy isoflavones, red clover) within 1 month prior to the start of the study

  • Use of any food supplement containing probiotics or postbiotics or regularconsumption (>3 days/week) of foods containing probiotics (including yogurt withadded 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 ofthe study

  • Participants with a new diagnosis of mental health disorder in the last 12 months orwith an unstable or uncontrolled mental health disorder in the opinion of theInvestigator

  • 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 untreatedor unstable

  • History of gastrointestinal surgery 6 months prior to the start of the study, withthe exception of appendicectomy

  • Regular intake (>3 days/week) of medication that affects microbiota or bowelmovements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate)

  • History of coronary disease, myocardial infarction, unstable angina, or previouscoronary angioplasty

  • History of venous thromboembolism (VTE) or known to be high risk for VTE due toinherited or acquired thrombophilia (such as factor V Leiden, antiphospholipidsyndrome)

  • History of stroke or transient ischaemic attack

  • History of severe renal dysfunction as defined by an estimated glomerular filtrationrate <30 mL/minute or severe liver dysfunction defined as established cirrhosis oractive liver disease with alanine aminotransferase (ALT) >3 × upper limit of normalat baseline

  • Initiated for new diagnosis or changed dose of UK-approved therapeutic medication ornutraceuticals for a medical condition that can affect study outcomes according tothe Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90days prior to study entry

  • Diagnosis of primary or secondary immunodeficiency including acquiredimmunodeficiency 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 islikely to prevent the participant from complying with the requirements of the studyor completing the study

  • Currently participating in another study or having participated in one within 3months prior to the start of the study

  • The participant is pregnant, planning a pregnancy, or breastfeeding

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
October 25, 2026

Connect with a study center

  • FutureMeds Glasgow

    Glasgow 2648579, Glasgow G20 7BE
    United Kingdom

    Active - Recruiting

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