NCT04713735已完成不适用
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population
Mead Johnson Nutrition2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年2月8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
- 76
- 试验地点
- 2
- 主要终点
- Number of Respiratory Tract Infections
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on respiratory tract infections (RTIs) in an elderly population in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 55 years of age at time of consent
- •Able to eat and drink, with assistance if required
- •Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study
- •Signed consent obtained from subject or legally authorized representative
- •Signed authorization obtained to use and/or disclose Protected Health Information
排除标准
- •Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition
- •Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation
- •Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject
- •Known allergy or intolerance to study products
- •On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months
- •Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration
- •Have experienced Respiratory Tract Infection within 1 week prior to randomization
结局指标
主要结局
Number of Respiratory Tract Infections
时间窗: 365 days
次要结局
- Comprehensive Metabolic Panel(Baseline, Day 45, Day 90, Day 180, and Day 365)
- Short Form (12) Health Survey Version 2 (SF-12v2®)(Baseline, Day 45, Day 90, Day 180, and Day 365)
- COVID Vaccine specific inflammatory panel(Day 45, Day 90, Day 180, Day 270, and Day 365)
- Complications from Respiratory Tract Infections(365 days)
- Duration of Respiratory Tract Infection(365 days)
- Number of Respiratory Tract Infections(180 days)
- Salivary level of thiocyanate(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Microorganism causing Respiratory Tract Infection(365 days)
- Salivary level of lactoferrin(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Complete Blood Count(Baseline, Day 45, Day 90, Day 180, and Day 365)
- Influenza Hemagglutination-inhibition Antibody Titer(Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28)
- Severity of Respiratory Tract Infection(365 days)
- Inflammatory cytokine(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Body Weight(Baseline, Day 45, Day 90, Day 180, and Day 365)
- Treatment of Respiratory Tract Infections(365 days)
- Level of protective antibody against influenza virus(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Salivary level of hypohalous acid(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Use of medical treatments(365 days)
- Cytokine Panel(Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28)
- Protection against apoptosis and oxidative stress(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
- Medically confirmed Adverse Events(365 days)
研究者
研究点 (2)
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