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Completed

NCT Number: NCT04960878

The Effect of Synbiotics on the Upper Respiratory Tract Infection

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synbiotic

Dietary Supplement

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

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. The incidence of the upper respiratory tract infection

    Time frame: Up to 8 weeks

Secondary outcomes

  1. The duration of the upper respiratory tract infection

    Time frame: Up to 8 weeks

  2. The severity of the upper respiratory tract infection

    Time frame: Up to 8 weeks

    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.

  3. Changes in the gut mictobiota

    Time frame: Baseline, 4 weeks, 8 weeks

    Changes in the composition, diversity, and function of gut mictobiota in feces will be measured by 16S rRNA gene sequencing.

  4. Changes in the levels of sIgA in saliva and feces

    Time frame: Baseline, 4 weeks, 8 weeks

  5. Changes in the levels of inflammatory cytokine

    Time frame: Baseline, 4 weeks, 8 weeks

    Changes in the levels of fasting plasma inflammatory cytokine, including CRP, IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ.

  6. Changes in the number of T, B, NK and monocytes populations

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  7. Changes in the subpopulation frequencies of blood lymphocyte and dendritic cells

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

  8. Change in body weight

    Time frame: Baseline, 4 weeks, 8 weeks

  9. Change in BMI

    Time frame: Baseline, 4 weeks, 8 weeks

  10. Change in body fat composition

    Time frame: Baseline, 4 weeks, 8 weeks

  11. Change in the levels fasting plasma glucose

    Time frame: Baseline, 4 weeks, 8 weeks

  12. Changes in the levels of fasting plasma TC, TG, LDL, and HDL

    Time frame: Baseline, 4 weeks, 8 weeks

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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