The Effect of Synbiotics on the Upper Respiratory Tract Infection

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960878
• Other study ID #: 2020S042
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: July 2021
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 5, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Gut Microbiota
• Immune Function
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Dietary Supplement:
• Synbiotic
Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.
• Placebo
Maltodextrin

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of the upper respiratory tract infection		Up to 8 weeks
Secondary	The duration of the upper respiratory tract infection		Up to 8 weeks
Secondary	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
Secondary	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
Secondary	Changes in the levels of sIgA in saliva and feces		Baseline, 4 weeks, 8 weeks
Secondary	Changes in the levels of inflammatory cytokine	Changes in the levels of fasting plasma inflammatory cytokine, including CRP, IL-1ß, IL-6, IL-8, IL-10, TNF-a, and IFN-?.	Baseline, 4 weeks, 8 weeks
Secondary	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
Secondary	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
Secondary	Change in body weight		Baseline, 4 weeks, 8 weeks
Secondary	Change in BMI		Baseline, 4 weeks, 8 weeks
Secondary	Change in body fat composition		Baseline, 4 weeks, 8 weeks
Secondary	Change in the levels fasting plasma glucose		Baseline, 4 weeks, 8 weeks
Secondary	Changes in the levels of fasting plasma TC, TG, LDL, and HDL		Baseline, 4 weeks, 8 weeks