Upper Respiratory Tract InfectionNCT04960878
The Effect of Synbiotics on the Upper Respiratory Tract Infection
A study testing Synbiotic in people with Upper Respiratory Tract Infection and Gut Microbiota, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection, Gut Microbiota, Immune Function
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2020to 5 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-65 years；
- good general health as determined by medical questionnaires;
- BMI <35 kg/m2;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Synbiotic, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1.5 g maltodextrin in a sachet once daily for 8 weeks. Receives: Dietary Supplement: Placebo |
| 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. Receives: Dietary Supplement: Synbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the upper respiratory tract infection
Measured: Up to 8 weeks
Secondary outcomes (12)
The duration of the upper respiratory tract infection
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Changes in the levels of sIgA in saliva and feces
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Change in body weight
Measured: Baseline, 4 weeks, 8 weeks
Change in BMI
Measured: Baseline, 4 weeks, 8 weeks
Change in body fat composition
Measured: Baseline, 4 weeks, 8 weeks
Change in the levels fasting plasma glucose
Measured: Baseline, 4 weeks, 8 weeks
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start5 Oct 2020
- Primary completion20 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
- Investigators
- Liegang Liu, PhD, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960878
- Sponsor's protocol ID
- 2020S042
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Synbiotics on the Upper Respiratory Tract Infection in Healthy Subjects: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT04960878
- Acronym / sponsor ID
- 2020S042
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1.5 g maltodextrin in a sachet once daily for 8 weeks. |
| Synbiotic | Experimental | Dietary Supplement: Synbiotic1.5 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-65 years；
- good general health as determined by medical questionnaires;
- BMI <35 kg/m2;
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynbioticSynbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides. | Dietary supplement | Synbiotic |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
The incidence of the upper respiratory tract infection
Time frame: Up to 8 weeks
12 secondary outcomes
The duration of the upper respiratory tract infection
Time frame: Up to 8 weeks
The severity of the upper respiratory tract infection
Time frame: Up to 8 weeks
Changes in the gut mictobiota
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
Time frame: 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 subpopulation frequencies of blood lymphocyte and dendritic cells
Time frame: Baseline, 4 weeks, 8 weeks
Change in body weight
Time frame: Baseline, 4 weeks, 8 weeks
Change in BMI
Time frame: Baseline, 4 weeks, 8 weeks
Change in body fat composition
Time frame: Baseline, 4 weeks, 8 weeks
Change in the levels fasting plasma glucose
Time frame: Baseline, 4 weeks, 8 weeks
Changes in the levels of fasting plasma TC, TG, LDL, and HDL
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liegang Liu, PhD principal investigator
Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Upper Respiratory Tract Infection and Gut Microbiota, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of the upper respiratory tract infection (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.