The Effect of Synbiotics on the Upper Respiratory Tract Infection
- Conditions
- Upper Respiratory Tract InfectionImmune FunctionGut Microbiota
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Synbiotic
- Registration Number
- NCT04960878
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- aged 18-65 years；
- good general health as determined by medical questionnaires;
- BMI <35 kg/m2;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 1.5 g maltodextrin in a sachet once daily for 8 weeks. Synbiotic 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.
- Primary Outcome Measures
Name Time Method The incidence of the upper respiratory tract infection Up to 8 weeks
- Secondary Outcome Measures
Name Time Method Changes in the number of T, B, NK and monocytes populations Baseline, 4 weeks, 8 weeks Changes in the number of T-lymphocytes(CD45+CD3+), B-lymphocytes(CD45+CD19+), monocytes(CD45+CD14+), and natural killer cells(CD45+CD56+) in blood samples were evaluated by flow cytometer.
The duration of the upper respiratory tract infection Up to 8 weeks The severity of the upper respiratory tract infection Up to 8 weeks The severity of the upper respiratory tract infection was assessed using the 24-item Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Paricipants were required to answer the question, "Did you have any symptom of upper respiratory tract infection today"? If someone answered "yes", he/she was instructed to complete WURSS-24 surveys daily.
Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells Baseline, 4 weeks, 8 weeks Changes in the subpopulation of blood lymphocytes (the levels of CD3+, CD4+, CD8+, and CD25+) and dendritic cells (the levels of CD3-CD19-CD56-HLA-DR+ CD11c+cells and CD3-CD19-CD56-HLA-DR+CD123+ cells ) in blood samples were evaluated by flow cytometer.
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 Changes in the composition, diversity, and function of gut mictobiota in feces will be measured by 16S rRNA gene sequencing.
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 Changes in the levels of fasting plasma inflammatory cytokine, including CRP, IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ.
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
Trial Locations
- Locations (1)
Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China