The Effect of Synbiotics on the Upper Respiratory Tract Infection

July 13, 2021 updated by: Liegang Liu, Huazhong University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of the upper respiratory tract infection
Time Frame: Up to 8 weeks
Up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The duration of the upper respiratory tract infection
Time Frame: Up to 8 weeks
Up to 8 weeks
The severity of the upper respiratory tract infection
Time Frame: 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.
Up to 8 weeks
Changes in the gut mictobiota
Time Frame: 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.
Baseline, 4 weeks, 8 weeks
Changes in the levels of sIgA in saliva and feces
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
Changes in the levels of inflammatory cytokine
Time Frame: 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.
Baseline, 4 weeks, 8 weeks
Changes in the number of T, B, NK and monocytes populations
Time Frame: 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.
Baseline, 4 weeks, 8 weeks
Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells
Time Frame: 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.
Baseline, 4 weeks, 8 weeks
Change in body weight
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
Change in BMI
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
Change in body fat composition
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
Change in the levels fasting plasma glucose
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liegang Liu, PhD, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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