NCT06348095已完成不适用
Effect of Probiotic WecProB on the Course of Mycoplasma Pneumoniae Pneumonia in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mycoplasma pneumoniae load
研究概览
简要总结
To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae pneumonia, in comparison 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
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MPP based on typical clinical manifestations (e.g., fever, cough, abnormal pulmonary auscultation), radiographic evidence of pneumonia on chest imaging, and laboratory findings in accordance with current pediatric community-acquired pneumonia guidelines;
- •MP infection was confirmed in nasopharyngeal secretions and serum samples using PCR and ELISA;
- •age between 6 months and 12 years;
- •disease duration less than 2 weeks;
- •written informed consent provided by the guardians.
排除标准
- •Previous history of wheezing;
- •Cardiovascular disease and congenital tracheal dysplasia;
- •pneumonia induced by other causes;
- •Dysplasia of bronchial and pulmonary tracts;
- •premature infants;
- •Combined with immunosuppressive diseases;
- •Presence of mental illness.
研究组 & 干预措施
Probiotics group
Experimental
10B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.
干预措施: Probiotic (Dietary Supplement)
Placebo group
Placebo Comparator
Dextrin, one strip/ day, before meals; Storage: Store in a cool, dry place without sun exposure.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Mycoplasma pneumoniae load
时间窗: 7 天
Mycoplasma pneumoniae load was detected by tNGS
次要结局
未报告次要终点
研究者
研究点 (1)
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