Menopausal Symptoms Probiotic Study (NCT06446869) | Clinical Trial Compass
RecruitingNot Applicable
Menopausal Symptoms Probiotic Study
United Kingdom140 participantsStarted 2024-09-10
Plain-language 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
Who can participate
Age range42 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mont…