Menopausal Symptoms Probiotic Study
- Conditions
- Menopause
- Registration Number
- NCT06446869
- Lead Sponsor
- Community Pharmacology Services Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoea<br> for less than 2 years<br><br> - Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35<br> or more per week recorded daily for 14 consecutive days)<br><br> - BMI between 18.5 and 34.9 kg/m2<br><br> - Menopause rating score II (MRS-II) total score of 9 or more at baseline visit<br><br> - Willing to sign Informed Consent Form<br><br> - Willing to not make relevant changes to their current dietary or lifestyle habits<br> during study<br><br> - Able to follow study procedures<br><br> - If perimenopausal, agrees to use an accepted method of contraception for duration of<br> study.<br><br>Exclusion Criteria:<br><br> - History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or<br> endometrial cancer, breast cancer, or cancers associated with sex hormones<br><br> - Use of hormonal replacement therapy, hormone analogues, or oral contraceptives<br> within 3 months prior to the start of the study<br><br> - Intake of herbal or food supplements with known effects on menopause symptoms within<br> 1 month prior to the start of the study. Examples of prohibited substances are black<br> cohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop [Humulus lupulus<br> L.], soy isoflavones, red clover) within 1 month prior to the start of the study<br><br> - Use of any food supplement containing probiotics or postbiotics or regular<br> consumption (>3 days/week) of foods containing probiotics (including yogurt with<br> added probiotics or bifidus effect) within 1 month prior to the start of the study<br><br> - Use of oral (>3 days) or parenteral antibiotics within 1 month prior to the start of<br> the study<br><br> - Participants with a new diagnosis of mental health disorder in the last 12 months or<br> with an unstable or uncontrolled mental health disorder in the opinion of the<br> Investigator<br><br> - Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus<br><br> - Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease<br> (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome<br><br> - History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreated<br> or unstable<br><br> - History of gastrointestinal surgery 6 months prior to the start of the study, with<br> the exception of appendicectomy<br><br> - Regular intake (>3 days/week) of medication that affects microbiota or bowel<br> movements, namely laxatives like polyethylene glycol or stimulant laxatives<br> (bisacodyl, sennosides, sodium pyrosulfate)<br><br> - History of coronary disease, myocardial infarction, unstable angina, or previous<br> coronary angioplasty<br><br> - History of venous thromboembolism (VTE) or known to be high risk for VTE due to<br> inherited or acquired thrombophilia (such as factor V Leiden, antiphospholipid<br> syndrome)<br><br> - History of stroke or transient ischaemic attack<br><br> - History of severe renal dysfunction as defined by an estimated glomerular filtration<br> rate <30 mL/minute or severe liver dysfunction defined as established cirrhosis or<br> active liver disease with alanine aminotransferase (ALT) >3 × upper limit of normal<br> at baseline<br><br> - Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or<br> nutraceuticals for a medical condition that can affect study outcomes according to<br> the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90<br> days prior to study entry<br><br> - Diagnosis of primary or secondary immunodeficiency including acquired<br> immunodeficiency syndrome, immunodeficiency, or active oncologic disease<br><br> - Known or suspected alcohol or drug abuse<br><br> - Any other surgical or medical condition, which in the opinion of the Investigator,<br> may place the participant at higher risk from her participation in the study, or is<br> likely to prevent the participant from complying with the requirements of the study<br> or completing the study<br><br> - Currently participating in another study or having participated in one within 3<br> months prior to the start of the study<br><br> - The participant is pregnant, planning a pregnancy, or breastfeeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess Impact
- Secondary Outcome Measures
Name Time Method Impact on Severity of Symptoms;Impact on number of Hot Flashes / Night Sweats;Impact on Intensity of Hot Flashes / Night Sweats;Impact on QoL;Impact on Depression, Anxiety and Stress;Impact on levels of reproductive hormones;Impact on serum inflammation markers;Impact on gut microbiota composition;Impact on digestive tolerance;Safety of the IP;Satisfaction of Use