allergic rhinitis
Conditions
Interventions
probiotic group:Take a probiotic product ((Bifidobacterium infantis CCFM111)) for 20 weeks, 1 sachet per day at bedtime
Probiotics + placebo group:Probiotic product for 8 weeks, then placebo (Maltodextrin) for 12 weeks, taken at bedtime, 1 sachet per day
placebo group:Take placebo for 20 weeks, 1 sachet per day at bedtime
Sponsors
Wuxi Children's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: Individuals must meet all of the following criteria to be eligible for the test: (1) The child has a positive skin prick test (the skin prick test, SPT) or abnormal specific IgE levels to at least one of the four common perennial allergens (dust mites, German cockroach, animal dander, and mold); (2) The presence of more than 2 allergic rhinitis symptoms including nasal congestion, runny nose, itching, paroxysmal sneezing, etc., and the persistence or accumulation of daily symptoms for more than 1 hour; (3) Children with moderate or above perennial allergic rhinitis, with reference to the classification and judgment criteria of "China Allergic Rhinitis Diagnosis and Treatment Guidelines 2022 Edition"; (4) Children aged 3-12 years, male or female; (5) Good compliance, able to comply with the requirements of this clinical trial and not to violate the regulations; (6) Only oral/intranasal antihistamines (H1A), intranasal glucocorticosteroids (INCS), and oral glucocorticosteroids (OCS) are allowed to be used during the probiotic treatment period, and the use of the drugs should be recorded in the CSMS.
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following criteria will be excluded from this trial: (1) allergy or intolerance to probiotic products or placebo; (2) immunosuppressed patients; patients with a history of malignant disease; patients with respiratory disease, particularly asthma (except mild intermittent asthma); patients with psychiatric disorders; and patients with any other condition that would interfere with the evaluation of the results of the trial; (3) Patients who received allergen specific immunotherapy (AIT) during the treatment period; (4) Patients who have repeatedly taken probiotic products or consumed yogurt in the previous month; (5) Patients (legal guardians) who refused to sign the informed consent form, or patients with poor estimated compliance and poor likelihood of follow-up; (6) Other cases that did not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| combined symptom and medication score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of immunological indices in serum and nasal lavage fluid;Security Analysis; | — |
Countries
China
Contacts
Public ContactQianger Zhuang
Wuxi Children's Hospital
Outcome results
None listed