Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

Wecare Probiotics

Status: Enrolling

Conditions: Allergic Rhinitis

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06680102

WK2024010

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Probiotic Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Maltodextrin