Study of the Preventive Effects and Mechanisms of Yeast β-Glucan on Upper Respiratory Tract Infec… (NCT07085858) | Clinical Trial Compass
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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 range18 Years – 35 Years
SexALL
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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
✕. Use of antibiotics, osmotic laxatives (e.g., magnesium sulfate, lactulose), anthraquinone-containing agents (e.g., rhubarb, aloe, senna), or gastrointestinal motility-promoting drugs (e.g., metoclopramide, domperidone, cisapride) within 1 month prior to screening;
What they're measuring
1
Incidence of Upper Respiratory Tract Infections (URTIs)
Timeframe: From enrollment to the end of intervention at 12 weeks
. Diagnosed with non-allergic rhinitis (e.g., vasomotor rhinitis, infectious rhinitis, hormonal rhinitis, drug-induced rhinitis), or with nasal polyps, severe nasal septum deviation, cerebrospinal fluid rhinorrhea, or aspirin-exacerbated respiratory disease (AERD);
✕. Patients with uncontrolled allergic comorbidities, including sinusitis, otitis media, allergic asthma, or atopic dermatitis;
✕. History of serious gastrointestinal diseases (e.g., severe diarrhea, inflammatory bowel disease), or gastrointestinal endoscopy within the past month;
✕. Diagnosed with congenital genetic disorders, primary immunodeficiency diseases, severe systemic illnesses, or malignancies;
✕. Influenza vaccination within the past 6 months;
✕. Pregnant or lactating women, or women with plans to conceive during the study period.