NCT02262091已完成不适用
Strengthening Immunity of Prefrail and Frail Elderly by WGP
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline at 4 weeks post-vaccination in antibody titers levels
研究概览
简要总结
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female elderly volunteers equal or above age of 70
- •Pre-frail and frail subjects (based on Fried's criteria)
- •Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
- •Having obtained his/her (or his/her legal representative's) informed consent
排除标准
- •Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
- •Allergy to eggs or influenza vaccine components.
- •Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
- •Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
- •Subject who has taken antibiotics in the last 2 months prior to entering the study.
- •Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
- •Personal or family history of Guillain-Barre syndrome
- •BMI>35 kg/m2
- •Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
- •Subject who cannot be expected to comply with the study procedures
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
结局指标
主要结局
Change from baseline at 4 weeks post-vaccination in antibody titers levels
时间窗: Up to 1 month
次要结局
- Measure of seroprotection(Up to 2 months)
- Measure the occurence of clinical endpoints(Up to 2 months)
- Measure of seroconversion(Up to 2 months)
- Measure of cytokines production(Up to 2 months 2014)
研究者
研究点 (2)
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