Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

NCT ID: NCT06680102

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2025-03-25

Brief Summary

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

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotic Group

Probiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily.

Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Placebo Group

Gummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day.

Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Interventions

Probiotic

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Voluntarily and in writing, sign an informed consent form agreeing to participate in this 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 "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)";

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

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

Exclusion Criteria

1. Use of drugs affecting the gut microbiota (including antimicrobial agents, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, 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 immunodeficiency diseases;

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

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 it impossible to determine efficacy or with incomplete data;

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

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

16. Other participants deemed ineligible by the researcher.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Luoyang, Henan, China

Countries

China

Other Identifiers

WK2024010

Identifier Type: -

Identifier Source: org_study_id