Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

Last updated: September 30, 2025
Sponsor: Wecare Probiotics Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

Probiotic

Placebo

Clinical Study ID

NCT06676111
WK2024009
  • Ages 4-14
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary, written, and signed informed consent form, agreeing to participate inthis study;

  2. Capable of completing research according to the requirements of the experimentalplan;

  3. Age range: 4-14 years old;

  4. Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosisand Treatment of Allergic Rhinitis in Children (Revised 2022)";

  5. 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;

  6. Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.

Exclusion

Exclusion Criteria:

  1. 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;

  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 immunodeficiencydiseases;

  7. Regular use of probiotics or prebiotics within the first 6 months of the screeningperiod;

  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;

  11. Stop taking the test sample or add other drugs midway, unable to determine efficacyor incomplete data;

  12. Short term use of substances with similar functions to the test subject affects thejudgment of the results;

  13. The subject is unable to participate in the trial due to personal reasons;

  14. Participants deemed unsuitable by other researchers to participate. Those who meetany of the above conditions shall not be selected.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Probiotic
Phase:
Study Start date:
October 10, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Site Not Available

  • Henan University of Science and Technology

    Luoyang 1801792, Henan 1808520 471000
    China

    Site Not Available

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