NCT06446869招募中不适用
Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Assess Impact
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 42 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Willing to sign Informed Consent Form
- •Willing to not make relevant changes to their current dietary or lifestyle habits during study
- •Able to follow study procedures
- •If perimenopausal, agrees to use an accepted method of contraception for duration of study.
排除标准
- •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
- •Use of oral (>3 days) or parenteral antibiotics within 1 month prior to the start of the study
- •Participants with a new diagnosis of mental health disorder in the last 12 months or with an unstable or uncontrolled mental health disorder in the opinion of the Investigator
- •Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus
- •Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome
- •History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreated or unstable
- •History of gastrointestinal surgery 6 months prior to the start of the study, with the exception of appendicectomy
- •Regular intake (>3 days/week) of medication that affects microbiota or bowel movements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate)
- •History of coronary disease, myocardial infarction, unstable angina, or previous coronary angioplasty
- •History of venous thromboembolism (VTE) or known to be high risk for VTE due to inherited or acquired thrombophilia (such as factor V Leiden, antiphospholipid syndrome)
- •History of stroke or transient ischaemic attack
- •History of severe renal dysfunction as defined by an estimated glomerular filtration rate <30 mL/minute or severe liver dysfunction defined as established cirrhosis or active liver disease with alanine aminotransferase (ALT) >3 × upper limit of normal at baseline
- •Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or nutraceuticals for a medical condition that can affect study outcomes according to the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90 days prior to study entry
- •Diagnosis of primary or secondary immunodeficiency including acquired immunodeficiency syndrome, immunodeficiency, or active oncologic disease
- •Known or suspected alcohol or drug abuse
- •Any other surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study
- •Currently participating in another study or having participated in one within 3 months prior to the start of the study
- •The participant is pregnant, planning a pregnancy, or breastfeeding
研究组 & 干预措施
Gyntima Menopause
Experimental
Study treatment
干预措施: Gyntima Menopause (Dietary Supplement)
Placebo
Placebo Comparator
Placebo comparator arm
干预措施: Placebo (Other)
结局指标
主要结局
Assess Impact
时间窗: 120 days
To assess the impact of the investigational product on the symptoms and quality of life (QoL) in menopausal women as assessed by Menopause Rating Score II (MRS-II) Each of the 11 symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale (an appropriate box is to be ticked). The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.
次要结局
- Impact on QoL(120 days)
- Impact on number of Hot Flashes / Night Sweats(120 days)
- Impact on Severity of Symptoms(120 days)
- Impact on digestive tolerance(120 days)
- Impact on Depression, Anxiety and Stress(120 days)
- Impact on levels of reproductive hormones(120 days)
- Impact on serum inflammation markers(120 days)
- Impact on Intensity of Hot Flashes / Night Sweats(120 days)
- Satisfaction of Use(120 days)
- Impact on gut microbiota composition(120 days)
- Safety of the IP(120 days)
研究者
研究点 (1)
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