The Effect of Synbiotics on the Upper Respiratory Tract Infection

Huazhong University of Science and Technology58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Upper Respiratory Tract Infection Gut Microbiota Immune Function

Interventions

SynbioticDIETARY_SUPPLEMENT

Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.

PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * aged 18-65 years； * good general health as determined by medical questionnaires; * BMI \<35 kg/m2; Exclusion Criteria: * 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.

Locations (1)

Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

The incidence of the upper respiratory tract infection

Time frame: Up to 8 weeks

Secondary Outcomes

The duration of the upper respiratory tract infection

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 4 weeks, 8 weeks

Changes in the levels of sIgA in saliva and feces

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 4 weeks, 8 weeks

Data from ClinicalTrials.gov

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