A Double-Blind, Randomized, Placebo-Controlled Trial of AHCC® Supplementation for Prevention of Respiratory Tract Infections Among Children Age 4-6 Years Old
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Incidence of Respiratory Tract Infection
研究概览
简要总结
This is a study to evaluate the effects of a prebiotic, AHCC, a standardized extract of cultured Lentinula edodes mycelia, on immunologic markers and the incidence of respiratory tract infections in children.
详细描述
A three-month, randomized, double-blind, placebo-controlled, pilot study will be performed in Indonesian healthy children aged 4 to 6 years in Nursery Schools. Subjects will be administered dextrin alone (placebo) or dextrin including AHCC. The incidence of RTI will be the primary outcome, and changes in serum Interferon Gamma (IFN-γ) as the crucial cytokine that acts as anti infective in the immune system will be the secondary outcome. Following completion of the 3 months intervention, participants will enter a 5 months follow up period (Months 4-8). New onset adverse events, ongoing adverse events, serious adverse events, and investigator assessed intervention related adverse events will be collected and evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 4-6 years old at the time of enrolment
- •Good nutritional status with weight-for-height > -2, and height-for-age z-score > -2 based on WHO growth standards
- •Infants in a group setting (daycare centers).
- •No congenital disorder
- •Not suffering from severe coughing or diarrhoea at the time of recruitment
- •Written informed consent will be obtained from parents or legal guardians before enrollment.
排除标准
- •Presence of chronic illnesses or conditions (congenital disorder, genetic syndromes, congenital heart disease, chronic renal failure, cystic fibrosis, etc)
- •Children who have participated in another clinical intervention study within the past 30 days.
- •Children who are likely to be transferred to another facility that is not part of the study before completing the follow-up period
研究组 & 干预措施
Active arm of the intervention study
This is the active arm of the intervention study.Subjects will be administered dextrin including AHCC.
干预措施: a prebiotic, that us a standardized extract of cultured Lentinula edodes mycelia (Dietary Supplement)
Control arm of the intervention study
This is the control arm of the intervention study. Subjects will be administered dextrin alone (placebo)
干预措施: Placebo (dextrin) (Dietary Supplement)
结局指标
主要结局
Incidence of Respiratory Tract Infection
时间窗: 3 months
the number incidence of infections, specifically respiratory tract infection, by looking at the number of febrile days (\>37.5 ◦C) during the test period.
次要结局
- additional immunological effects(3 months)
- additional nutritional effect- WAZ score(3 months)
- additional nutritional effect- Weight in gram(3 months)
- additional nutritional effect- HAZ score(3 months)
- additional nutritional effect- Height in cm(3 months)
- additional nutritional effect- WHZ score(3 months)
- additional nutritional effect- Head circumference in cm(3 months)
研究者
Conny Tanjung
Principal Investigator
Hasanuddin University