Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Indonesian Elementary School Children: a Double Blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Serum IgA
研究概览
简要总结
This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA
详细描述
The type of the study is double blind randomize placebo-controlled trial with minimum 72 subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125 mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from elementary school in Yogyakarta District.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children at age of 7-9 years
- •have normal body mass index (BMI) i.e. -2 ≤ z-score < +1, slightly overweight z-score < +1.5, and slightly underweight z-score > -3.
排除标准
- •allergic to milk
- •consuming other probiotic product
- •he/she do not want to stop consumption & doing washout for 2 weeks.
研究组 & 干预措施
Treatment Group
Received UHT milk + paraprobiotic Lactobacillus plantarum IS-10506 5 x 1010 CFU/day (125 mL) for 90 days
干预措施: UHT Milk + Lactobacillus plantarum IS-10506 (Dietary Supplement)
Placebo Group
Received UHT milk (125 mL) for 90 days
干预措施: UHT Milk (Dietary Supplement)
结局指标
主要结局
Serum IgA
时间窗: 90 days
Measuring IgA (ng/mL) in collected serum
Serum IgG
时间窗: 90 days
Measuring IgG (ng/mL) in collected serum
Faecal sIgA
时间窗: 90 days
Measuring sIgA (ng/mL) in collected feses
Serum IgM
时间窗: 90 days
Measuring IgM (ng/mL) in collected serum
次要结局
- Weight(90 days)
- Height(90 days)
研究者
DR.Siti Helmyati, DCN, M.Kes
Principal Investigator
Gadjah Mada University