NCT00294788Unknown1 期
Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects
Probiomics Ltd2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The percentage enhancement of the immune response to Fluvax vaccine by PCC® compared to placebo as measured by hemagglutination inhibition (HAI) titre in the serum of subjects 4 weeks after vaccination
研究概览
简要总结
This project aims to test the hypothesis that oral consumption of a specific strain of the probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly enhance the immune response to a vaccine for influenza.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons must be adult men and women aged 18-49 years (have not reached 50th birthday).
- •Persons must be able and willing to provide informed consent.
- •Persons must be willing to receive the influenza vaccine (Fluvax®) given as an intramuscular injection.
- •Persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study.
- •Persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture.
- •Persons must be willing to notify study personnel of a range of health effects by questionnaire.
排除标准
- •Any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including HIV infection) or on-going immunosuppressive therapy.
- •Currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination.
- •Allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin.
- •A prior serious reaction to a vaccine, or have had Guillain-Barre syndrome.
- •Received an influenza vaccine in the past.
- •Received any other vaccine within one month prior to enrolment
- •Are participating in another research study involving any study medication
结局指标
主要结局
The percentage enhancement of the immune response to Fluvax vaccine by PCC® compared to placebo as measured by hemagglutination inhibition (HAI) titre in the serum of subjects 4 weeks after vaccination
次要结局
- Increase in T cell cytokine expression; Decrease in incidence of respiratory tract illness, an improvement in general intestinal health, and a reduction in the severity of adverse side effects of the injection
研究者
研究点 (2)
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