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

Community Pharmacology Services Ltd1 个研究点分布在 1 个国家目标入组 140 人2024年9月10日

适应症Menopause

干预措施Gyntima Menopause Placebo

概览

阶段: 不适用
干预措施: Gyntima Menopause
疾病 / 适应症: Menopause
发起方: Community Pharmacology Services Ltd
入组人数: 140
试验地点: 1
主要终点: Assess Impact
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2024年9月10日

结束日期

2026年10月25日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Community Pharmacology Services Ltd

责任方

Sponsor

入排标准

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

研究组 & 干预措施

Gyntima Menopause

Study treatment

干预措施: Gyntima Menopause

Placebo

Placebo comparator arm

干预措施: Placebo

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.