Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diarrhea
- Sponsor
- Zhejiang University
- Enrollment
- 4000
- Locations
- 1
- Primary Endpoint
- Clinical outcomes of diarrhoeal disease in children
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mizu Jiang
Chief physician, professor, doctoral supervisor, secretary of gastroenterology group, pediatrics branch of Chinese medical association, pediatric gastroenterologist
Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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。
Outcomes
Primary Outcomes
Clinical outcomes of diarrhoeal disease in children
Time Frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
symptom remission rate of children with diarrhoea
Secondary Outcomes
- 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)