Registry and Clinical Observation of Children With Diarrhoeal Disease

• Conditions: Diarrhea

• Registration Number: NCT05052489
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2021-07-21
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-12
• Last Update Submitted: 2021-09-12
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22
• Primary Completion: 2021-12
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Under the age of 18

  • Children diagnosed with diarrhea, including:

    1. Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors
    2. Persistent chronic diarrhea:

Including the following diseases:

1. Food allergy, food intolerance, indigestion, etc.;
2. Inflammatory bowel disease (IBD);
3. Diarrhoeal irritable bowel syndrome;
4. Antibiotic associated diarrhea (AAD);
5. Others: chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc 3. Volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent

Exclusion Criteria

1. Class A infectious diseases associated with diarrhoea (cholera, plague)
2. Children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。
3. Children receiving long-term immunosuppressive therapy (except children with IBD)。
4. Children with gastrointestinal surgery and tumor;
5. In addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes of diarrhoeal disease in children	acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days	symptom remission rate of children with diarrhoea

Secondary Outcome Measures

Name	Time	Method
Direct medical costs	acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days	including drugs, laboratory tests, treatment, emergency care, and other (all-cause) medical expenses
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	Change from baseline in stool consistency during the period of observation
safety evaluation	acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days	The proportion of Adverse events and serious adverse events

Trial Locations

Locations (1)

Children's Hospital Affiliated to Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China