Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Clinical outcomes of diarrhoeal disease in children
研究概览
简要总结
This Study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea Therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and therapeutic effect of childhood diarrhea, safety monitoring data, and provide reliable data support for the clinical application.
详细描述
To evaluate the causes, clinical manifestations, treatment plans and clinical outcomes of diarrhoeal disease in children in a real diagnosis and treatment setting。 Evaluate the effect of different treatment schemes in actual clinical application,the clinical use of nutrition-supported zinc in oral rehydration fluids,the influencing factors of clinical efficacy, including the demographic characteristics and clinical characteristics of the children, as well as drug combination regimens, etc. To evaluate the clinical use of antibiotics,the clinical effects of different probiotics in the treatment of diarrhoeal disease in children,the effectiveness, safety and economy of the dose course of the clinical application of Clostridium butyricum bivariate living agents, the medical costs and resource consumption of treatment for diarrhoeal diseases in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under the age of 18
- •Children diagnosed with diarrhea, including:
- •Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors
- •Persistent chronic diarrhea:
- •Including the following diseases:
- •Food allergy, food intolerance, indigestion, etc.;
- •Inflammatory bowel disease (IBD);
- •Diarrhoeal irritable bowel syndrome;
- •Antibiotic associated diarrhea (AAD);
- •Others: chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc
- •Volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent
排除标准
- •Class A infectious diseases associated with diarrhoea (cholera, plague)
- •Children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。
- •Children receiving long-term immunosuppressive therapy (except children with IBD)。
- •Children with gastrointestinal surgery and tumor;
- •In addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。
结局指标
主要结局
Clinical outcomes of diarrhoeal disease in children
时间窗: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
symptom remission rate of children with diarrhoea
次要结局
- Direct medical costs(acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days)
- Influencing factors of clinical outcomes(acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days)
- effectiveness of combined clostridium butyricum and bifidobacterium powders(acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days)
- safety evaluation(acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days)
研究者
Mizu Jiang
Chief physician, professor, doctoral supervisor, secretary of gastroenterology group, pediatrics branch of Chinese medical association, pediatric gastroenterologist
Zhejiang University