Skip to content

Registry and Clinical Observation of Children With Diarrhoeal Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05052489
Enrollment
4000
Registered
2021-09-22
Start date
2021-09-30
Completion date
2022-05-31
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

probiotics, children

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.

Interventions

OTHERregisty

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

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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。

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcomes of diarrhoeal disease in childrenacute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 dayssymptom remission rate of children with diarrhoea

Secondary

MeasureTime frameDescription
Influencing factors of clinical outcomesacute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 days
Direct medical costsacute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 daysincluding drugs, laboratory tests, treatment, emergency care, and other (all-cause) medical expenses
effectiveness of combined clostridium butyricum and bifidobacterium powdersacute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 daysChange from baseline in stool consistency during the period of observation
safety evaluationacute diarrhea up to 14 days;persistent diarrhea and chronic diarrhea up to 28 daysThe proportion of Adverse events and serious adverse events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026