Menopausal Symptoms Probiotic Study
ConditionMenopause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age42-60
SponsorCommunity Pharmacology Services Ltd
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Gyntima Menopause
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Community Pharmacology Services Ltd
Lead sponsor
Kaneka Americas Holding Inc.
Collaborator
Source ClinicalTrials.gov