Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

To evaluate the effect of probiotic gummies on symptoms of allergic rhinitis, immune-inflammatory factors, and host metabolism in children with allergic rhinitis compared with placebo.

Inclusion Criteria: * (1) voluntary participation with written informed consent obtained prior to study enrollment; (2) ability to comply with the study procedures in accordance with the trial protocol; (3) age between 4 and 14 years, inclusive; (4) meeting the diagnostic criteria for AR as outlined in the Guidelines for the Diagnosis and Treatment of Pediatric AR (2022 Revised Edition); (5) presence of at least two of the following symptoms: sneezing, watery rhinorrhea, nasal itching, or nasal congestion, with a total daily symptom duration exceeding one hour, either continuously or cumulatively, and potentially accompanied by ocular manifestations such as ocular itching, tearing, or conjunctival hyperemia; (6) clinical signs including pale and edematous nasal mucosa, with or without watery nasal discharge. Exclusion Criteria: 1. use of medications affecting intestinal flora (e.g., antibacterial drugs, microecological agents, intestinal mucosa protectants, Chinese patent medicines) for more than one continuous week within one month prior to screening; 2. patients with pulmonary tuberculosis; 3. patients with allergic asthma; 4. patients with nasal polyps or severe nasal septum deviation; 5. patients with severe systemic diseases or malignant tumors; 6. patients with congenital genetic diseases or congenital immune deficiency diseases; 7. patients who have regularly used probiotics or prebiotics within 6 months prior to screening; 8. patients with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.); 9. patients with metabolic syndrome symptoms (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.); 10. patients with sinusitis, otitis media, or respiratory tract infections; 11. patients who are allergic to the components of the probiotics used in this trial; 12. patients who have stopped taking the test sample or have taken other drugs midway, making it impossible to determine efficacy or having incomplete data; 13. patients whose recent use of substances with functions similar to the test sample could interfere with the accurate judgment of the trial results; 14. subjects who are unable to participate in the trial due to their own reasons; (15) other subjects deemed ineligible for participation by the researchers.