Registry and Clinical Observation of Children With Diarrhoeal Disease

Diarrhea Clinical Trial

Official title:

Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052489
• Other study ID #: MJiang-001
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: May 2022

Study information

• Verified date: September 2021
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: May 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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?

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• registy
Children with diarrhea were registered in the hospital. Baseline information of the children was recorded and followed up to observe the distribution of disease types, clinical manifestations, treatment plans and clinical outcomes

Locations

Country	Name	City	State
China	Children's Hospital Affiliated to Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes of diarrhoeal disease in children	symptom remission rate of children with diarrhoea	acute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days
Secondary	Influencing factors of clinical outcomes		acute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days
Secondary	Direct medical costs	including drugs, laboratory tests, treatment, emergency care, and other (all-cause) medical expenses	acute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days
Secondary	effectiveness of combined clostridium butyricum and bifidobacterium powders	Change from baseline in stool consistency during the period of observation	acute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days
Secondary	safety evaluation	The proportion of Adverse events and serious adverse events	acute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days