Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

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

• 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;
• patients with pulmonary tuberculosis;
• patients with allergic asthma;
• patients with nasal polyps or severe nasal septum deviation;
• patients with severe systemic diseases or malignant tumors;
• patients with congenital genetic diseases or congenital immune deficiency diseases;
• patients who have regularly used probiotics or prebiotics within 6 months prior to screening;
• patients with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
• patients with metabolic syndrome symptoms (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
• patients with sinusitis, otitis media, or respiratory tract infections;
• patients who are allergic to the components of the probiotics used in this trial;
• patients who have stopped taking the test sample or have taken other drugs midway, making it impossible to determine efficacy or having incomplete data;
• patients whose recent use of substances with functions similar to the test sample could interfere with the accurate judgment of the trial results;
• subjects who are unable to participate in the trial due to their own reasons; (15) other subjects deemed ineligible for participation by the researchers.