Registry and Clinical Observation of Children With Diarrhoeal Disease

NCT ID: NCT05052489

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-05-31

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.

Conditions

Diarrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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。

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Mizu Jiang

Chief physician, professor, doctoral supervisor, secretary of gastroenterology group, pediatrics branch of Chinese medical association, pediatric gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital Affiliated to Zhejiang University Medical College

Hangzhou, Zhejiang, China

Countries

China

Facility Contacts

Mizu Jiang

Role: primary

Other Identifiers

MJiang-001

Identifier Type: -

Identifier Source: org_study_id