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The Effect of Synbiotics on the Upper Respiratory Tract Infection

Primary Purpose

Upper Respiratory Tract Infection, Gut Microbiota, Immune Function

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Synbiotic
Placebo
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Synbiotic

Arm Description

1.5 g maltodextrin in a sachet once daily for 8 weeks.

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.

Outcomes

Primary Outcome Measures

The incidence of the upper respiratory tract infection

Secondary Outcome Measures

The duration of the upper respiratory tract infection
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.
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.
Changes in the levels of sIgA in saliva and feces
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.
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.
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.
Change in body weight
Change in BMI
Change in body fat composition
Change in the levels fasting plasma glucose
Changes in the levels of fasting plasma TC, TG, LDL, and HDL

Full Information

First Posted
June 29, 2021
Last Updated
July 13, 2021
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04960878
Brief Title
The Effect of Synbiotics on the Upper Respiratory Tract Infection
Official Title
The Effect of Synbiotics on the Upper Respiratory Tract Infection in Healthy Subjects: A Randomized Double-Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection, Gut Microbiota, Immune Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1.5 g maltodextrin in a sachet once daily for 8 weeks.
Arm Title
Synbiotic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic
Intervention Description
Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
The incidence of the upper respiratory tract infection
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
The duration of the upper respiratory tract infection
Time Frame
Up to 8 weeks
Title
The severity of the upper respiratory tract infection
Description
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
Title
Changes in the gut mictobiota
Description
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
Title
Changes in the levels of sIgA in saliva and feces
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Changes in the levels of inflammatory cytokine
Description
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
Title
Changes in the number of T, B, NK and monocytes populations
Description
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
Title
Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in body weight
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in BMI
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in body fat composition
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in the levels fasting plasma glucose
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Organizational Affiliation
Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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The Effect of Synbiotics on the Upper Respiratory Tract Infection

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