PROGLOW- The impact of Probiotics on General well-being and Life Outcomes in Women.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cultech Ltd.
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- 1.Any changes in overall Quality of Life & Well Being assessed using participant completed
研究概览
简要总结
This trial is expanding on thatobservation to investigate whether daily supplementation with the Lab4probiotic (as viable bacteria or inactive heat-killed bacteria) can impact uponwell-being in a cohort of middle-aged women. The trial will be a doubleblinded, 3-arm, randomized, placebo-controlled, parallel group superioritystudy consisting of 75 women (as assigned at birth), aged 40-60. Eachparticipant will provide two fecal samples, two vaginal swabs and two bloodsamples during the course of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Females (assigned at birth) aged 40 to 60 2.Willing to provide fecal samples, blood samples and vaginal swabs 3.BMI of less than 25 kg/m2 4.Willing to maintain normal diet and lifestyle during the study 5.Willing to refrain from taking other probiotic supplements during the study.
排除标准
- •1.Consumption of oral antibiotics within the last 3 months 2.Regular consumption of probiotics within the last 1 month prior to the study 3.Premature menopause (onset before age of 40),
- •Undergone hysterectomy or ovariectomy
- •Given birth in the last 3 months, currently pregnant or planning pregnancy 6.Receiving hormone replacement therapy 7.Shift worker
- •Immunodeficient or undergoing immunosuppressive therapy 9.Diagnosed with diabetes/cardiovascular disease/cancer/dementia
- •Unexplained loss of weight in recent months.
结局指标
主要结局
1.Any changes in overall Quality of Life & Well Being assessed using participant completed
时间窗: Day 1, Day 56, Day 112 for questionnaires (Athens insomnia scale and Hospital anxiety and depression scales). Once every week from Day 1 to Day 112 for Weekly well-being diary.
questionnaires (Weekly well-being diary, Athens insomnia scale and Hospital anxiety and depression scales)
时间窗: Day 1, Day 56, Day 112 for questionnaires (Athens insomnia scale and Hospital anxiety and depression scales). Once every week from Day 1 to Day 112 for Weekly well-being diary.
次要结局
- 1. Any changes in the composition of the fecal and/or vaginal microbiomes.
- 2. Any changes in circulating bio-markers.(Day 1 and Day 112)
- 3. Any changes in the Rey auditory verbal learning test.(Day 1, Day 56, Day 112)