The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health (NCT04001088) | Clinical Trial Compass
CompletedPhase 2
The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health
United States144 participantsStarted 2019-07-29
Plain-language summary
This Phase II study is designed to evaluate the potential effects of a novel probiotic supplement on the severity of global menopause symptoms (e.g., psychological, somatic, urogenital symptoms) and on bone health in postmenopausal women.
Who can participate
Age range40 Years – 59 Years
SexFEMALE
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Inclusion Criteria:
* Healthy post-menopausal woman
* Last menstrual period has occurred at least 12 months prior to screening
* ≥40 to \<60 years old
* Vaginal pH ≥ 5
* MRS score ≥ 20
* Willing and able to give written informed consent
* Willing to consume IP or placebo, complete questionnaires, records, and daily diaries associated with the study and to complete all clinical study visits
* Willingness to discontinue consumption of probiotic supplements and food containing added probiotics and/or prebiotics (e.g. yogurts with live, active cultures or supplements) o Note: Screened participants will be eligible to participate after completing a 4-week wash-out period.
Exclusion Criteria:
* Milk or soy allergy
* Women with induced menopause through full or partial hysterectomy, chemotherapy or radiation
* Consumption of natural health products used to treat menopausal symptoms such as phytoestrogens, Black Cohosh, dehydroepiandrosterone (DHEA), Dong Quai, vitamin E (\>250 IU/day), high consumption of soy food products, unless a 1-month wash-out period has been completed prior to study commencement
* Currently undergoing or have previously undergone HT for treatment of menopausal symptoms, unless a three-month washout has been completed prior to study commencement
* Active vaginal infections/abnormalities (e.g. active urinary tract infection (UTI), genital hemorrhage of unknown origin)
o Note: Screened participants with infections would be eligible to participate 4 weeks a…
What they're measuring
1
Change from baseline in the global Menopause Rating Scale (MRS) score
Timeframe: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.