Moderate-to-Severe Allergic Rhinitis
Conditions
Interventions
Intervention group:Lacticaseibacillus paracasei SINEFREE, 10 billion CFU per sachet, one sachet once daily, taken with warm water, for 8 weeks.
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6–12 years; 2. Diagnosed with perennial moderate-to-severe allergic rhinitis according to the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022, Revised Edition), with a disease duration of >= 2 years and a Nasal Symptom Visual Analog Scale (VAS) score of >= 5; 3. Informed consent for participation with both the legal guardian(s) and the child participant (aged 8 years or older) providing joint assent/consent;
Exclusion criteria
Exclusion criteria: 1.Presence of significant underlying medical conditions, including but not limited to: Congenital malformations; Immunodeficiency disorders; Inherited metabolic diseases; Irritable bowel syndrome (IBS); Ulcerative colitis; Intellectual disabilities or neurodevelopmental disorders; 2.Comorbided with nasal conditions, including but not limited to chronic sinusitis, nasal septal deviation, or sinonasal neoplasms; 3.Presenting with gastrointestinal symptoms, including but not limited to diarrhea, vomiting, or constipation, within one week prior to enrollment; 4.Presenting with symptoms indicative of a respiratory infection, such as fever, sore throat, cough, or productive sputum, within one week prior to enrollment; 5.Intolerance to orally administered probiotics; 6.Have undergone allergen-specific immunotherapy within the past five years; 7.Using medications that may interfere with trial outcomes, and the washout period is shorter than the required duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count (CBC);Modified Lund-Kennedy Endoscopic Scoring System;Total Ocular Symptom Score (TOSS);Intestinal flora;Metabolomics;Visual Analog Scale (VAS);Allergy test;Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ);Cytokine; | — |
Countries
China
Contacts
Public ContactLi Hong
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed