Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Immune response rate for H1N1, H3N2 and Phu-B virus
研究概览
简要总结
This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
详细描述
This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B between study group and control group. The study group receives influenza vaccine and drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor and investigators are blinded throughout the study.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 45 years old
- •healthy and having normal vital signs
- •no history of uncontrolled systemic or autoimmune diseases
- •no signs or symptoms of respiratory infection
- •normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar
- •no history of influenza vaccine during the past 6 months
- •able to continuously take the intervention daily for 6 weeks
- •able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection
- •accepted to receive influenza vaccine shot
- •able to refrain from receiving other vaccine during the trial
- •able to refrain from traveling to endemic area of influenza
- •able to communicate in Thai and sign their written inform consent
排除标准
- •under pregnancy or expected to be pregnant
- •lactose or milk protein intolerances
- •daily intake of probiotic product for one month prior to recruitment
- •chronic alcoholism
- •GI disturbance e.g. stomachache, frequent diarrhea or constipation
- •history of GI surgery
- •ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids
结局指标
主要结局
Immune response rate for H1N1, H3N2 and Phu-B virus
时间窗: 4 weeks after vaccination
Number of subjects with increased HAI titer from baseline divided by total number of subjects
次要结局
- Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus(0, 2, 6 and 8 weeks after baseline)
- Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus(0, 2, 6 and 8 weeks after baseline)
- Antibody response rate for influenza A (H1N1+H3N2) virus(4 weeks after vaccination)
- Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus(0, 2, 6 and 8 weeks after baseline)
研究者
Dunyaporn Trachootham
Assistant Professor
Mahidol University