Effect of Probiotic on Rhinovirus Induced Colds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 主要终点
- Number of Participants With Rhinovirus-associated Illness Episodes
研究概览
简要总结
This is a randomized, double-blind placebo controlled trial to evaluate the effect of a probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the experimental rhinovirus challenge model. A previous study documented that Bl-04 has significant effects on the innate immune response in the nose and this study will be powered to assess whether these effects translate into a demonstrable clinical benefit. Volunteers will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary analysis will be on the proportion of volunteers who develop a rhinovirus associated illness in the two treatment groups.
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
- Triple (Participant, 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
- •INCLUSION CRITERIA AT ENROLLMENT:
- •Subject must be 18-60 years of age.
- •Subject must read and sign a copy of the approved Consent Form
- •Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39
- •INCLUSION CRITERIA AT DAY -28
- •Female subjects must be using an effective birth control method.
- •INCLUSION CRITERIA AT CHALLENGE:
- •Female subjects must be using an effective birth control method.
排除标准
- •Antibiotic use within 3 months prior to day -28
- •Female subjects with a positive urine pregnancy screen
- •History of use of probiotics in the preceding two weeks
- •Current cancer diagnosis or immunosuppressive therapy in the last 6 months
- •Any clinically significant abnormalities of the upper respiratory tract
- •Any clinically significant acute or chronic respiratory illness
- •Any clinically significant bleeding tendency by history
- •Hypertension that requires treatment with antihypertensive medications
- •History of angina or other clinically significant cardiac disease
- •Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
- •History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
- •History of drug or alcohol abuse in the 6 months preceding the study
- •EXCLUSION CRITERIA AT CHALLENGE:
- •Any upper respiratory infection or allergic rhinitis in the two weeks prior to the challenge
- •Female subjects with positive pregnancy screen prior to challenge
- •Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
- •Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold or allergy preparation in the two weeks prior to the challenge
研究组 & 干预措施
Bifidobacterium lactis Bl-04
2*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier
干预措施: Bifidobacterium animalis subsp. lactis Bl-04 (Biological)
Placebo
sucrose
干预措施: sucrose (Other)
结局指标
主要结局
Number of Participants With Rhinovirus-associated Illness Episodes
时间窗: 5 days
Rhinovirus-associated illness episodes: Volunteers who have both a rhinovirus infection and a symptomatic illness will be defined as having a rhinovirus-associated common cold illness.
次要结局
未报告次要终点
研究者
Ronald Turner, MD
Professor, Department of Pediatrics
University of Virginia