Children With Allergic Rhinitis
Conditions
Brief summary
To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.
Interventions
DIETARY_SUPPLEMENTProbiotic
The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)
DIETARY_SUPPLEMENTPlacebo
The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)
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, written, and signed informed consent form, agreeing to participate in this study; 2. Capable of completing research according to the requirements of the experimental plan; 3. Age range: 4-14 years old; 4. Meets the diagnostic criteria for AR established in the Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022); 5. Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, tearing, and redness; 6. Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.
Exclusion criteria
1. Drugs that affect the intestinal flora (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening; 2. Merge with tuberculosis patients; 3. Combined with allergic asthma; 4. Patients with nasal polyps or severe nasal septum deviation; 5. Patients with serious systemic diseases or malignant tumors; 6. Individuals with congenital genetic disorders or congenital immunodeficiency diseases; 7. Regular use of probiotics or prebiotics within the first 6 months of the screening period; 8. Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.); 9. Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.); 10. Patients with combined sinusitis, otitis media, or respiratory infections; 11. Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data; 12. Short term use of substances with similar functions to the test subject affects the judgment of the results; 13. The subject is unable to participate in the trial due to personal reasons; 14. Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | 56 days | Score 0 - asymptomatic; Score 1 - mild symptoms, easily tolerated; Score 2 - moderate symptoms, annoying but tolerable; Score 3 - Severe symptoms, intolerable, affecting daily life and sleep. Add them together to get the total score |
| Visual Analogue Scale (VAS) | 56 days | 0 means no such symptoms; 10 means that this symptom is the most severe. Add them together to get the total score |
| Rhinoconjunctivitis-related quality of life questionnaire (RQLQ) | 56 days | 0 points: no trouble; 1 point: little to no distress; 2 points: occasional distress; Score 3: Moderate degree of distress; 4: Somewhat bothered, 5: Very bothered; Score 6: Extremely distressed |
| Medication scores | 56 days | Scoring drugs include oral antihistamines (3 points/tablet, maximum 6 points), oral leukotriene receptor antagonists (2 points/dose), nasal glucocorticoids (1 point/spray, maximum 8 points), nasal spray or eye drops antihistamines (0.5 points/spray or drop, maximum 4 points), and the daily average score for the past 1 week was calculated. |
Countries
China
Outcome results
None listed