Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

Recruitment & Eligibility

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.

Study & Design

Primary Outcome Measures

Name	Time	Method
Improvement of rhinitis symptoms in participants	8 weeks	Improvement in Nasal symptoms was assessed using the Total Nasal Symptom Score(TNSS), which included four common nasal symptoms: itchiness, nasal congestion, sneezing, and runny nose. The four symptoms were scored using a "four-point scale", that is, according to the severity of each symptom from 0 to 3 points, that is, the higher the score, the more severe the symptoms, and the total score of the entire TNSS score is the sum of the four symptom scores, which ranges from 0 to 12 points.

Secondary Outcome Measures

Name	Time	Method
16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention	8 weeks	Changes in subjects' fecal microbiota, including abundance and proportion of beneficial bacteria, were assessed by 16S rRNA sequencing before and after probiotic intervention.
Effect of probiotic intervention on immunoglobulin in subjects	8 weeks	The changes of Immunoglobulin A and Immunoglobulin E before and after intervention were detected by ELISA.
Impact on Serum Inflammatory Cytokines	8 weeks	Levels of IL-4, IL-5, IL-10, IL-13.

Recruitment & Eligibility