Study of the Effects and Mechanisms of Yeast Postbiotics on Persistent Allergic Rhinitis Symptoms (NCT07079748) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of the Effects and Mechanisms of Yeast Postbiotics on Persistent Allergic Rhinitis Symptoms
China80 participantsStarted 2025-07-25
Plain-language summary
This study is designed as a randomized, double-blind, placebo-controlled human intervention trial among university students with persistent allergic rhinitis (AR) symptoms. The aim is to evaluate the effectiveness of yeast postbiotics in alleviating persistent AR symptoms and to explore the potential mechanisms by which yeast postbiotics modulate the gut microbiota to improve AR-related outcomes. A stratified randomization method will be applied to assign participants into the yeast postbiotic group and the placebo group. Stratification will be based on(1) Sex (male/female), and (2) Physician-diagnosed AR status (yes/no, based on self-reported clinical history), ensuring comparability between the two groups. During the intervention period, participants in the yeast postbiotic group will take two capsules of yeast postbiotic supplements daily after meals, while the placebo group will take two placebo capsules, identical in appearance and composition except without the active ingredients. The total study duration is 15 weeks, including a 1-week run-in period, 12-week intervention, and 2-week follow-up after the intervention.
All participants will be asked to complete a daily nasal symptom score (TNSS) and report any adverse events. At week 0, week 4, and week 12, follow-up assessments will be conducted, including: symptom and quality-of-life questionnaires (e.g., VAS, RQLQ), dietary intake surveys, anthropometric measurements (height, weight, body fat percentage), and biological sample collection (including blood, urine, saliva, and feces). Additionally, saliva samples will be collected specifically at week 2 of the intervention to assess mucosal immune markers.
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
Total Nasal Symptom Score (TNSS)
Timeframe: Through intervention completion (Week 0 to Week 12)
. 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;
✕. Pregnant or lactating women, or women with plans to conceive during the study period.