Menopausal Symptoms Probiotic Study

Community Pharmacology Services Ltd

Status: Enrolling

Conditions: Menopause

Treatments: Other: Placebo; Dietary Supplement: Gyntima Menopause

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06446869

KNK-DONACARE

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: Female

Ages: 42 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

Gyntima Menopause

Experimental group

Description:

Study treatment

Treatment:

Dietary Supplement: Gyntima Menopause

Placebo

Placebo Comparator group

Description:

Placebo comparator arm

Treatment:

Other: Placebo