The Effect of Synbiotics on the Upper Respiratory Tract Infection

NCT04960878 | Completed

• 1 other identifier: 2020S042
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection; Gut Microbiota; Immune Function

Outcome Measures

Primary Outcomes (1)

• The incidence of the upper respiratory tract infection

  Up to 8 weeks

Secondary Outcomes (12)

• The duration of the upper respiratory tract infection

  Up to 8 weeks

• The severity of the upper respiratory tract infection

  Up to 8 weeks

• Changes in the gut mictobiota

  Baseline, 4 weeks, 8 weeks

• Changes in the levels of sIgA in saliva and feces

  Baseline, 4 weeks, 8 weeks

• Changes in the levels of inflammatory cytokine

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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.

Dietary Supplement: Synbiotic

Interventions

Synbiotic DIETARY_SUPPLEMENT

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

Synbiotic

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years；
• good general health as determined by medical questionnaires;
• BMI \<35 kg/m2;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Liegang Liu, PhD

  Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 14, 2021
• Study Start: October 5, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 5, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

CN (1)