Children With Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
The experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8).
DIETARY_SUPPLEMENTPlacebo
The experimental phase of this study lasts 8 weeks and each patient will have 3 visits (week0, week4, week8).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes allergic rhinitis symptoms before and after the intervention. | Week 0 and Week 8 | The assessment was done using three scales: VAS (Visual Analog Scale), TNSS (Total Nasal Symptom Score), and TTNNSS (Total Nasal and Non-Nasal Symptom Score). VAS quantifies overall symptom severity on a 0-10 visual scale (0 = no symptoms, 10 = extremely severe), with higher scores indicating a heavier symptom burden. TNSS uses a 0-3 scale to semi-quantitatively evaluate four core nasal symptoms, with each symptom scored from 0 to 3, giving a total score range of 0-12. TNNSS uses a 0-3 scoring system to semi-quantitatively analyze non-nasal symptoms, with a total score range of 0-15. For all three scales, higher scores indicate more severe symptoms. |
Countries
China
Outcome results
None listed