Phase
Condition
Common Cold
Allergy
Nasal Obstruction
Treatment
Probiotic
Placebo
Clinical Study ID
Ages 4-14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary, written, and signed informed consent form, agreeing to participate inthis study;
Capable of completing research according to the requirements of the experimentalplan;
Age range: 4-14 years old;
Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosisand Treatment of Allergic Rhinitis in Children (Revised 2022)";
Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasalitching, and nasal congestion. Symptoms last or accumulate for more than 1 hour perday, and may be accompanied by eye symptoms such as itching, tearing, and redness;
Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.
Exclusion
Exclusion Criteria:
Drugs that affect the intestinal flora (including antibacterial drugs, probiotics,intestinal mucosal protective agents, traditional Chinese patent medicines andsimple preparations, etc.) are continuously used for more than one week within onemonth before screening;
Merge with tuberculosis patients;
Combined with allergic asthma;
Patients with nasal polyps or severe nasal septum deviation;
Patients with serious systemic diseases or malignant tumors;
Individuals with congenital genetic disorders or congenital immunodeficiencydiseases;
Regular use of probiotics or prebiotics within the first 6 months of the screeningperiod;
Individuals with severe gastrointestinal diseases (including severe diarrhea,inflammatory bowel disease, etc.);
Those with metabolic syndrome (including obesity, abnormal lipid metabolism,hypertension, diabetes, etc.);
Patients with combined sinusitis, otitis media, or respiratory infections;
Stop taking the test sample or add other drugs midway, unable to determine efficacyor incomplete data;
Short term use of substances with similar functions to the test subject affects thejudgment of the results;
The subject is unable to participate in the trial due to personal reasons;
Participants deemed unsuitable by other researchers to participate. Those who meetany of the above conditions shall not be selected.
Study Design
Connect with a study center
Henan University of Science and Technology
Luoyang, Henan 471000
ChinaSite Not Available
Henan University of Science and Technology
Luoyang 1801792, Henan 1808520 471000
ChinaSite Not Available

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