The Effectiveness of Weizmannia Coagulans BC99 in Alleviating Allergic Rhinitis in Adults and Its Impact on the Gut Microbiota.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Improvement of rhinitis symptoms in participants
研究概览
简要总结
Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Probiotic (Dietary Supplement)
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.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Improvement of rhinitis symptoms in participants
时间窗: 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.
次要结局
- 16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention(8 weeks)
- Effect of probiotic intervention on immunoglobulin in subjects(8 weeks)
- Impact on Serum Inflammatory Cytokines(8 weeks)