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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1.5 g maltodextrin in a sachet once daily for 8 weeks. |
|
| Synbiotic | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of the upper respiratory tract infection | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of the upper respiratory tract infection | Up to 8 weeks | |
| The severity of the upper respiratory tract infection | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liegang Liu, PhD | Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Placebo | Dietary Supplement | Maltodextrin |
|
| Up to 8 weeks |
| Changes in the gut mictobiota | Changes in the composition, diversity, and function of gut mictobiota in feces will be measured by 16S rRNA gene sequencing. | 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 | Changes in the levels of fasting plasma inflammatory cytokine, including CRP, IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ. | Baseline, 4 weeks, 8 weeks |
| Changes in the number of T, B, NK and monocytes populations | 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. | Baseline, 4 weeks, 8 weeks |
| Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells | 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. | Baseline, 4 weeks, 8 weeks |
| Change in body weight | Baseline, 4 weeks, 8 weeks |
| Change in BMI | Baseline, 4 weeks, 8 weeks |
| Change in body fat composition | 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 |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |