Registry and Clinical Observation of Children With Diarrhoeal Disease

NCT05052489 | Unknown

• 1 other identifier: MJiang-001
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

probiotics; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Influencing factors of clinical outcomes

  acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days

• Direct medical costs

  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

Interventions

registy OTHER

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

1. Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors 2. Persistent chronic diarrhea,including: Food allergy, food intolerance, indigestion,Inflammatory bowel disease (IBD),Diarrhoeal irritable bowel syndrome,Antibiotic associated diarrhea (AAD),chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc.

You may qualify if:

• 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 3. Volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent

You may not qualify if:

• 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。

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Children's Hospital Affiliated to Zhejiang University Medical College

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, professor, doctoral supervisor, secretary of gastroenterology group, pediatrics branch of Chinese medical association, pediatric gastroenterologist

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CN (1)