NCT01258842Unknown3 期
Double-blind, Randomized, Placebo-controlled Trial of the Effects of Prophylactic Bifidobacterium Lactis HN019 Supplementation on the Incidence of Influenza Infection in Healthy Adults
Fonterra Research Centre4 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 426
- 试验地点
- 4
- 主要终点
- Influenza infection
研究概览
简要总结
To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy free-living men and women aged 18 to 60 years
- •Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
- •Subject owns a refrigerator and is willing to keep study product refrigerated at all times
- •Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects
- •Consent to the study and willing to comply with study product and methods
排除标准
- •Influenza vaccination in last 6 months, or any other vaccination in previous 15 days
- •Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- •Chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, COPD, as determined by medical history and baseline physical examination)
- •Chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin C)
- •Use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics)
- •Contraindication to dairy products or any other substance in the study product (eg, lactose intolerance)
- •History of alcohol, drug, or medication abuse
- •Pregnant or lactating female, or pregnancy planned during study period
- •Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 3 months of screening
- •Participation in another study with any investigational product within 3 months of screening
- •Investigator believes that the participant may be uncooperative and/or noncompliant, and should therefore not participate in the study
结局指标
主要结局
Influenza infection
时间窗: 12 weeks
Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
次要结局
- Symptom duration(12 weeks)
- Symptom severity(12 weeks)
- Adverse event incidence(12 weeks)
研究者
研究点 (4)
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