Clinical trial NCT06885346: Probiotics Improve Adult Allergic Rhinitis and Regulate Gut Microbiota
Official title: The Effectiveness of Weizmannia Coagulans BC99 in Alleviating Allergic Rhinitis in Adults and Its Impact on the Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

Voluntarily and in writing, sign an informed consent form agreeing to participate in this study; Able to complete the study as required by the trial protocol; Age between 18 and 65 years old; Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)"; 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; Signs: Pale and edematous nasal mucosa, which may be accompanied by watery secretions.-

Exclusion Criteria:

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; Patients with coexisting pulmonary tuberculosis; Patients with coexisting allergic asthma; Patients with nasal polyps or severe nasal septum deviation; Patients with severe systemic diseases or malignant tumors; Individuals with congenital genetic diseases or congenital immunodeficiency diseases; Regular use of probiotics or prebiotics within 6 months prior to the screening period; Patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.); Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.); Patients with sinusitis, otitis media, or respiratory tract infections; Individuals allergic to any components of the probiotics used in this trial; Pregnant or lactating women or those planning to conceive in the near future; Those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data; Recent use of products similar to the test function, affecting the judgment of the results; Participants who cannot participate in the trial due to their own reasons; Other participants deemed ineligible by the researcher. -

Primary outcomes:
measure: The variations in intestinal flora before and after the intervention were assessed using 16S rRNA sequencing.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: School of Food and Bioengineering, Henan University of Science and Technology
state: Henan
Study officials:
References: