The Effect of Synbiotics on the Upper Respiratory Tract Infection

The Effect of Synbiotics on the Upper Respiratory Tract Infection in Healthy Subjects: A Randomized Double-Blind Trial

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 Overview

• Status: Completed
• Conditions: Gut Microbiota; Immune Function; Upper Respiratory Tract Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Synbiotic

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 1.5 g maltodextrin in a sachet once daily for 8 weeks.	Dietary supplement: Placebo; Maltodextrin
Experimental: 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.	Dietary supplement: Synbiotic; Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of the upper respiratory tract infection	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Liegang Liu, PhD, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2020S042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No