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Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children | Clinical Trials | Clareo Health

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Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile

NCT06676111•Wecare Probiotics Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 14 years

Sex

ALL

Healthy Volunteers

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;
+4 more criteria

Locations (1)

Henan University of Science and Technology

Luoyang, Henan, China

Key Dates

Start Date

October 10, 2024

Primary Completion Date

February 10, 2025

Completion Date

July 31, 2025

Last Updated

October 6, 2025

Enrollment

ACTUAL participants

Conditions

Children With Allergic Rhinitis

Interventions

Probiotic

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT