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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure. |
|
| Placebo group | Placebo Comparator | No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | 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 | 56 days |
| Visual Analogue Scale (VAS) | "0" means no such symptoms; "10" means that this symptom is the most severe. Add them together to get the total score | 56 days |
| Rhinoconjunctivitis-related quality of life questionnaire (RQLQ) | 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 | 56 days |
| Medication scores | 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. | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan University of Science and Technology | Luoyang | Henan | 471000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41197269 | Derived | Han Z, Zhu H, Yang Y, Wang Y, Li X, Zhu J, Wu Y, Fang S, Gu S. Weizmannia coagulans BC99 alleviates pediatric allergic rhinitis via the gut microbiota-SCFAs- immunomodulatory axis: A randomized, double-blind, placebo-controlled trial. Int Immunopharmacol. 2026 Jan 1;168(Pt 1):115787. doi: 10.1016/j.intimp.2025.115787. Epub 2025 Nov 5. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8) |
|
| D019602 |
| Food and Beverages |