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.
Menopause is a natural phase in which a woman's menstrual cycle permanently cease. During this time, women undergo many biological changes, including a decline of estrogen level or alterations in the vaginal microflora. This can result in the onset of various physiological and psychological menopause-related symptoms which may continue into postmenopausal years. The present study aims to evaluate the potential effects of a probiotic supplement on global menopause symptoms including psychological, somatic and urogenital symptoms. It is hypothesized that this probiotic, consumed over a 12-week period, will help reduce the symptoms of menopause by modulating the mucosal microflora of the vaginal linings. Additionally, it is hypothesized that the continued consumption of this probiotic combination over a total of 48 weeks will aid in the overall maintenance of bone health and may ameliorate bone density loss. 144 healthy postmenopausal women (≥ 40 to \< 60 years old) in the U.S. who are experiencing menopause-related symptoms will be randomized to the study (12-week period), and a subset (72 postmenopausal women) will continue the study for an additional 36 weeks (Bone Health Study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
144
Altus Research
Lake Worth, Florida, United States
Health Awareness Inc.
Port Saint Lucie, Florida, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
Viable Research
Henderson, Nevada, United States
Change from baseline in the global Menopause Rating Scale (MRS) score
Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create a composite or total score. A higher score indicates a greater severity of menopausal symptoms.
Time frame: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Change from baseline in individual components of the Menopause Rating Scale (MRS) (psychological, somatic and urogenital symptoms)
Assessed using Menopause Rating Scale (MRS) rating scale. 11 questions on a scale from no complaints (0) to very severe symptoms (4). Subscores are added to create the 3 dimensions scores. A higher score indiactes a greater severity of perceived menopausal symptoms.
Time frame: Measured on weeks -2 (screening visit), 0, 4, 8, 12, and 48.
Change from baseline in vaginal pH
Vaginal swabs will be collected for pH testing, using pH strips for screening and to measure evolution of pH throughout first part of the study.
Time frame: Measured on weeks -2 (screening visit), 0, and 12.
Change from baseline in vaginal microbiota
Effects of the probiotic intervention on overall microbiota composition will be assessed with a vaginal swab. In addition, recovery of the probiotic strains in the vaginal samples will be assessed.
Time frame: Measured on weeks 0 and 12.
Change from baseline in the Patient Health Questionnaire (PHQ-9) total score
Depression measured with the Patient Health Questionnaire (PHQ-9). 10 questions. The first 9 questions are on a scale from not at all bothered by symptoms (0) to bothered by symptoms nearly everyday (3). To arrive at the total score, the individual question scores are added. A score of 5-9 indicates minimal symptoms, a score of 10-14 indicates minor depression, dysthymia, or mild Major Depression, a score of 15-19 indicates moderately sever Major Depression and a score of greater than 20 indicates severe Major Depression.
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Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) global score
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). 9 questions. It consists of seven components including: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component score ranges from 0 to 3, whereby 3 reflects the negative extreme, for a global score range of 0 to 21. A score of 5 or greater indicates the reporter has poor sleep quality.
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Vulvovaginal Symptoms Questionnaire (VSQ) total score.
Vulvar and vaginal atrophy measured with the Vulvovaginal Symptoms Questionnaire (VSQ). 21 yes (1) or no (0) questions in 4 scales: Symptoms, Emotions, Life-impact, Sexual impact. Total score will be the sum of the first 17 questions if non-sexually active or of the 21 questions if sexually active. A higher score indicates a greater severity of vulvar and vaginal atrophy.
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change in baseline in the Michigan Incontinence Symptom Index (M-ISI) mean score
Urinary incontinence measured with the Michigan Incontinence Symptom Index (M-ISI). 10 questions with different scales all numbered 0-4. The total score is derived from taking the mean of the 10 reported scores. A higher score indicates a higher severity of incontinence.
Time frame: Measured on weeks 0, 4, 8, 12, and 48.
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total score
Anxiety measured with the Generalized Anxiety Disorder-7 (GAD-7). 7 questions scaled from not at all sure (0) to nearly every day (3). Total score is derived from the addition of answer to each question. A higher score indicates a higher level of detected anxiety.
Time frame: Measured on weeks 0, 4, 8, 12, and 48.