Not Yet RecruitingNot Applicable

Study of the Preventive Effects and Mechanisms of Yeast β-Glucan on Upper Respiratory Tract Infections

China96 participantsStarted 2025-07-25

Plain-language summary

This study is designed as a randomized, double-blind, placebo-controlled human intervention trial targeting a population of university students with persistent allergic rhinitis (AR) symptoms. The primary objective is to evaluate the preventive effect and underlying mechanisms of yeast β-glucan on upper respiratory tract infections (URTIs), providing scientific evidence for the prophylactic use of prebiotics in high-risk populations. All participants will be stratified by sex and body mass index (BMI), and then randomly assigned to either the yeast β-glucan group or the control group. During the 15-week study period-including a 1-week run-in phase, a 12-week intervention phase, and a 2-week follow-up phase-participants in the intervention group will take two yeast β-glucan capsules daily after meals, while the control group will take two placebo capsules with identical appearance, taste, and packaging. Participants will be monitored daily for the occurrence of URTIs. In the event of an infection, the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess symptom severity and duration. Medication use, including dosage, frequency, and timing, will also be recorded. Weekly follow-ups will assess changes in Total Nasal Symptom Score (TNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and adverse events. In addition, participants will undergo comprehensive follow-up assessments at Week 0 and Week 12, including TNSS and RQLQ questionnaires, a 3-day dietary intake survey, anthropometric measurements (e.g., height, weight, body fat percentage), and biological sample collection (blood, urine, and stool samples).

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged between 18 and 35 years;
. Meeting the symptom criteria for persistent allergic rhinitis (AR) as defined in the Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition): (1) Symptoms: Two or more of the following-paroxysmal sneezing, watery rhinorrhea, nasal itching, and nasal congestion-lasting continuously or cumulatively for at least 1 hour per day; ocular symptoms such as tearing, itching, and redness may also be present; (2) Persistent AR: Symptoms occur on ≥4 days per week and persist for ≥4 consecutive weeks;
. No use of probiotics, prebiotics, synbiotics, antihistamines, corticosteroids, or immunosuppressants within 1 month prior to screening;
. Willing and able to maintain usual physical activity levels and dietary patterns during the study;
. Able and willing to sign the informed consent form voluntarily.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Upper Respiratory Tract Infections (URTIs)

Timeframe: From enrollment to the end of intervention at 12 weeks

Trial details

NCT IDNCT07085858

SponsorLanZhou University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Xiaoqin Li, Dr.Prof.

+86 15927366423 lixiaoqin@lzu.edu.cn

View on ClinicalTrials.gov More Upper Respiratory Tract Infections trials