Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of the Combination of Three Probiotic Strains on Quality of Life and Symptoms in Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Quality of life measured by the Cervantes Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in peri- and/or postmenopause period (up to 5 years after last menstruation) Perimenopause is defined as if changes in the menstrual cycle (such as longer or shorter cycles, absence of any menstrual cycle, or abnormally heavy or prolonged bleeding) have occurred in the previous 12 months.
- •Age 45-60 years.
- •Cervantes quality of life scale score ≥ 38 at the screening visit.
- •Willing to sign the informed consent.
- •Willing to maintain dietary or lifestyle habits during the study.
排除标准
- •Regular use of probiotics other than the probiotics under study (in the form of food supplements or in foods such as "bifidus" type yogurt) in the month prior to the baseline visit.
- •Use of oral or injectable antibiotics in the last month before the start of the study.
- •Women with history of hysterectomy (removal of the uterus) or ovariectomy (removal of the ovaries).
- •Diagnosis of active oncological disease.
- •Use of hormone replacement therapy (HRT), hormonal analogues or oral contraceptives in the 3 months prior to the start of the study.
- •Type 1 diabetes.
- •Untreated or unstable thyroid disease.
- •Diagnosis of severe renal, cardiac or hepatic disease.
- •Diagnosis of chronic gastrointestinal disease: inflammatory bowel disease (Crohns disease, ulcerative colitis), pancreatitis, short bowel syndrome.
- •Diagnosis of celiac disease
- •Regular intake of laxatives such as polyethylene glycol or irritant laxatives (bisacodyl, sennosides, sodium pyrosulphate) (+3 days/week).
- •Primary or secondary immunodeficiency: AIDS, immunoglobulin deficiency.
结局指标
主要结局
Quality of life measured by the Cervantes Scale
时间窗: Baseline, 30 days, 60 days, 90 days
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
Menopause-related symptoms evaluated by Menopause Rating Scale (MRS) scale
时间窗: Baseline, 30 days, 60 days, 90 days
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
次要结局
- Quality of life measured by the Cervantes Scale subscores(Baseline, 30 days, 60 days, 90 days)
- Menopause-related symptoms evaluated by MRS scale sub-scores(Baseline, 30 days, 60 days, 90 days)
- Utian Quality of Life scale(Baseline, 90 days)
- Gastrointestinal symptoms(Baseline, 90 days)
- Symptoms vaginal infections(Baseline, 30 days, 60 days, 90 days)
- Quality of life measured by the Cervantes Scale subscores(Baseline, 30 days, 60 days, 90 days)
- Menopause-related symptoms evaluated by MRS scale sub-scores(Baseline, 30 days, 60 days, 90 days)
- Utian Quality of Life scale(Baseline, 90 days)
- Gastrointestinal symptoms(Baseline, 90 days)
- Symptoms vaginal infections(Baseline, 30 days, 60 days, 90 days)