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NOT YET RECRUITING
NCT07079748
NA

Study of the Effects and Mechanisms of Yeast Postbiotics on Persistent Allergic Rhinitis Symptoms

Sponsor: LanZhou University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-07-25

Completion Date

2026-12-31

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Yeast Postbiotics

Participants in the intervention group will take two capsules of yeast postbiotics daily after meals, with each capsule containing 250 mg of yeast postbiotics, along with maltodextrin and silicon dioxide.

DIETARY_SUPPLEMENT

Placebo

Participants in the placebo group will take an equal number of placebo capsules, identical in dosage form, taste, appearance, and packaging. The placebo contains only maltodextrin and a small amount of silicon dioxide. All participants will take two capsules once daily, swallowed with warm water after meals.

Locations (1)

School of Public Health, Lanzhou University

Lanzhou, Gansu, China