Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

Last updated: July 1, 2025
Sponsor: Wecare Probiotics Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Acute Rhinitis

Treatment

Probiotic

Maltodextrin

Clinical Study ID

NCT06680102
WK2024010
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily and in writing, sign an informed consent form agreeing to participate inthis study;

  2. Able to complete the study as required by the trial protocol;

  3. Age between 18 and 65 years old;

  4. Meet the diagnostic criteria for allergic rhinitis established in the "ChineseGuidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 RevisedEdition)";

  5. Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea,nasal itching, and nasal congestion, with daily symptoms lasting or accumulating formore than 1 hour, which may be accompanied by eye itching, tearing, and redness ofthe eyes and other ocular symptoms;

  6. Signs: Pale and edematous nasal mucosa, which may be accompanied by waterysecretions.

Exclusion

Exclusion Criteria:

  1. Use of drugs affecting the gut microbiota (including antimicrobial agents,probiotics, intestinal mucosal protective agents, traditional Chinese patentmedicines, etc.) for more than 1 week within 1 month prior to screening;

  2. Patients with coexisting pulmonary tuberculosis;

  3. Patients with coexisting allergic asthma;

  4. Patients with nasal polyps or severe nasal septum deviation;

  5. Patients with severe systemic diseases or malignant tumors;

  6. Individuals with congenital genetic diseases or congenital immunodeficiencydiseases;

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

  8. Patients with severe gastrointestinal diseases (including severe diarrhea,inflammatory bowel diseases, etc.);

  9. Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension,diabetes, etc.);

  10. Patients with sinusitis, otitis media, or respiratory tract infections;

  11. Individuals allergic to any components of the probiotics used in this trial;

  12. Pregnant or lactating women or those planning to conceive in the near future;

  13. Those who discontinue the test sample or take other medications midway, making itimpossible to determine efficacy or with incomplete data;

  14. Recent use of products similar to the test function, affecting the judgment of theresults;

  15. Participants who cannot participate in the trial due to their own reasons;

  16. Other participants deemed ineligible by the researcher.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Probiotic
Phase:
Study Start date:
November 25, 2024
Estimated Completion Date:
March 25, 2025

Connect with a study center

  • School of Food and Bioengineering, Henan University of Science and Technology

    Luoyang, Henan 471000
    China

    Site Not Available

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