In this randomized, placebo-controlled, double-blind study, we aim to investigate if the active product consisting of a probiotic blend can improve the quality of life and alleviate symptoms in peri- and postmenopausal women, using validated questionnaires.
Fifty to 80% of women around menopause or already in postmenopause complain about symptoms such as hot flashes, night sweats, sleep disturbances, tiredness, and depression, which negatively impact their quality of life. The aim of this study was to evaluate the effects of a multiprobiotic strain on the quality of life and menopause-associated symptoms. The study is a de-centralized, prospective, randomized, placebo-controlled, double-blind study in which peri- and postmenopausal women will be recruited and randomly assigned (ratio 2:1) to receive either a probiotic blend or placebo formulation in capsules form for 12 weeks. We aim to recruit up to 300 women. On a monthly basis, quality of life will be evaluated by using the validated Spanish Quality of Life Cervantes questionnaire. In addition, other questionnaires will be administered to monitor menopause-related symptoms (Menopause Rating Scale, MRS) and health-related quality of life (Utian Quality of Life). This will be documented through a specifically designed, web-based platform. Main study variable is change in the global score in MRS scores and Cervantes quality of life scores throughout study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
245
HM Gabinete Velázquez
Madrid, Madrid, Spain
Quality of life measured by the Cervantes Scale
Changes in the Cervantes Scale T standardized score obtained using the mean and standard deviation of the population of young women (20-44 years). Cervantes scale is a validated questionnaire developed for Spanish population comprising 31 items which score from 0 to 5
Time frame: Baseline, 30 days, 60 days, 90 days
Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale
Changes in total MRS score throughout the study. MRS is a 11-item validated questionnaire, each item scoring from 0 to 4. Scores ranging from 0-4, 5-8, 9-15, and 16+ are used to rate the perceived symptoms as none/minimal, mild, moderate, and severe, respectively
Time frame: Baseline, 30 days, 60 days, 90 days
Quality of life measured by the Cervantes Scale subscores
Changes in the subscores of the different domains of the Cervantes® Scale: Menopause and Health, Psychological, Sexuality and Relationship.
Time frame: Baseline, 30 days, 60 days, 90 days
Menopause-related symptoms evaluated by MRS scale sub-scores
Changes in the subscores of the different domains of the MRS Scale: Vegetative, Urogenital and Mental.
Time frame: Baseline, 30 days, 60 days, 90 days
Utian Quality of Life scale
Changes in quality of life total score and sub-scores using the Utian Quality of Life (UQOL) scale. This scale measures quality of life in perimenopause period and comprises 23 items evaluating the following domains: occupational, health, emotional and sexual QOL
Time frame: Baseline, 90 days
Gastrointestinal symptoms
Assessment of digestive tolerance based on gastrointestinal symptoms documented on the Gastrointestinal Symptom Rating Scale (GSRS).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 90 days
Symptoms vaginal infections
Number of days with any of the following vaginal symptoms: itching, irritation or abnormal vaginal discharge.
Time frame: Baseline, 30 days, 60 days, 90 days