NCT06885632已完成不适用
Weizmannia Coagulans BC99 Gummy Alleviates Pediatric Allergic Rhinitis Via Modulating Gut Metabolism
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Changes in the structure of fecal microbiota before and after the intervention.
研究概览
简要总结
To evaluate the effect of probiotic gummies on symptoms of allergic rhinitis, immune-inflammatory factors, and host metabolism in children with allergic rhinitis compared with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) voluntary participation with written informed consent obtained prior to study enrollment; (2) ability to comply with the study procedures in accordance with the trial protocol; (3) age between 4 and 14 years, inclusive; (4) meeting the diagnostic criteria for AR as outlined in the Guidelines for the Diagnosis and Treatment of Pediatric AR (2022 Revised Edition); (5) presence of at least two of the following symptoms: sneezing, watery rhinorrhea, nasal itching, or nasal congestion, with a total daily symptom duration exceeding one hour, either continuously or cumulatively, and potentially accompanied by ocular manifestations such as ocular itching, tearing, or conjunctival hyperemia; (6) clinical signs including pale and edematous nasal mucosa, with or without watery nasal discharge.
排除标准
- •use of medications affecting intestinal flora (e.g., antibacterial drugs, microecological agents, intestinal mucosa protectants, Chinese patent medicines) for more than one continuous week within one month prior to screening;
- •patients with pulmonary tuberculosis;
- •patients with allergic asthma;
- •patients with nasal polyps or severe nasal septum deviation;
- •patients with severe systemic diseases or malignant tumors;
- •patients with congenital genetic diseases or congenital immune deficiency diseases;
- •patients who have regularly used probiotics or prebiotics within 6 months prior to screening;
- •patients with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
- •patients with metabolic syndrome symptoms (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
- •patients with sinusitis, otitis media, or respiratory tract infections;
- •patients who are allergic to the components of the probiotics used in this trial;
- •patients who have stopped taking the test sample or have taken other drugs midway, making it impossible to determine efficacy or having incomplete data;
- •patients whose recent use of substances with functions similar to the test sample could interfere with the accurate judgment of the trial results;
- •subjects who are unable to participate in the trial due to their own reasons; (15) other subjects deemed ineligible for participation by the researchers.
研究组 & 干预措施
Placebo group
Placebo Comparator
No probiotic pectin gummies/2 pellets/day
干预措施: Placebo (Dietary Supplement)
Probiotic group
Experimental
Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in the structure of fecal microbiota before and after the intervention.
时间窗: Week 0 and Week 8
Analyzed by 16S rRNA sequencing.
次要结局
未报告次要终点
研究者
研究点 (2)
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