Clinical trial NCT04960878: 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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection
Gut Microbiota
Immune Function
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The incidence of the upper respiratory tract infection
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: The duration of the upper respiratory tract infection
timeFrame: Up to 8 weeks
measure: The severity of the upper respiratory tract infection
timeFrame: Up to 8 weeks
measure: Changes in the gut mictobiota
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in the levels of sIgA in saliva and feces
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in the levels of inflammatory cytokine
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in the number of T, B, NK and monocytes populations
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in body weight
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in BMI
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in body fat composition
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in the levels fasting plasma glucose
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in the levels of fasting plasma TC, TG, LDL, and HDL
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
name: Liegang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: