The Effect of Synbiotics on the Upper Respiratory Tract Infection in Healthy Subjects: A Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The incidence of the upper respiratory tract infection
研究概览
简要总结
Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. Therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-65 years；
- •good general health as determined by medical questionnaires;
- •BMI <35 kg/m2;
排除标准
- •known congenital or acquired immune defects；
- •allergies and other chronic or acute diseases requiring treatment；
- •subjects with chronic gastrointestinal diseases;
- •alcohol or drug misuse or both；
- •pregnancy or lactation；
- •vaccination against influenza within the last 12 months；
- •use of oral antibiotics, probiotics, prebiotics, synbiotics, drugs active on gastrointestinal motility, or a laxative of any class within the last month.
研究组 & 干预措施
Placebo
1.5 g maltodextrin in a sachet once daily for 8 weeks.
干预措施: Placebo (Dietary Supplement)
Synbiotic
1.5 g synbiotics supplement of Lactobacillus rhamnosus HN001 (1.5×10^11 CFU) , Bifidobacterium lactis HN019 (7.5×10^10 CFU), and 500mg fructooligosaccharides in a sachet once daily for 8 weeks.
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
The incidence of the upper respiratory tract infection
时间窗: Up to 8 weeks
次要结局
- Changes in the number of T, B, NK and monocytes populations(Baseline, 4 weeks, 8 weeks)
- The duration of the upper respiratory tract infection(Up to 8 weeks)
- The severity of the upper respiratory tract infection(Up to 8 weeks)
- Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells(Baseline, 4 weeks, 8 weeks)
- Change in body weight(Baseline, 4 weeks, 8 weeks)
- Change in BMI(Baseline, 4 weeks, 8 weeks)
- Changes in the gut mictobiota(Baseline, 4 weeks, 8 weeks)
- Change in body fat composition(Baseline, 4 weeks, 8 weeks)
- Changes in the levels of sIgA in saliva and feces(Baseline, 4 weeks, 8 weeks)
- Changes in the levels of inflammatory cytokine(Baseline, 4 weeks, 8 weeks)
- Change in the levels fasting plasma glucose(Baseline, 4 weeks, 8 weeks)
- Changes in the levels of fasting plasma TC, TG, LDL, and HDL(Baseline, 4 weeks, 8 weeks)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology