Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 910
- 试验地点
- 2
- 主要终点
- The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination
研究概览
简要总结
To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly
详细描述
To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (>60 years), and monitored for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all health elderly aged ≥ 60 years
- •who came to the vaccination and health education activities in the entire East Jakarta District Health Center
- •with Body Mass Index (BMI) 17,5-29,9
- •healthy mental status (MMSE score of 28-30)
排除标准
- •subject who have contraindications to influenza vaccinations
- •are undergoing treatment related to immune system modulation in the past 4 weeks
- •therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study
- •recieved influenza vaccination less than one year before
- •Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.
研究组 & 干预措施
Vaccine
Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly
干预措施: Flubio (Biological)
Probiotic
Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic
干预措施: Lacidofil (Dietary Supplement)
Placebo Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
干预措施: Placebo Vaccine (Other)
Placebo probiotic
capsul
干预措施: Placebo probiotic (Other)
结局指标
主要结局
The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination
时间窗: 6 months
次要结局
- Percentage of subjects with anti HI titer >=1:40(6 months)
- Percentage subjects with increasing antibody titer >=4 times(6 months)
研究者
Sukamto Koesnoe
Principal investigator
Indonesia University