The Effect of Synbiotics on the Upper Respiratory Tract Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-01-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Respiratory Tract Infection Gut Microbiota Immune Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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.

Group Type EXPERIMENTAL

Synbiotic

Intervention Type DIETARY_SUPPLEMENT

Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.

Interventions

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Synbiotic

Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes