Clinical trial NCT05052489: Registry and Clinical Observation of Children With Diarrhoeal Disease
Official title: Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diarrhea
Keywords: probiotics
children
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 4000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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。

Primary outcomes:
measure: Clinical outcomes of diarrhoeal disease in children
timeFrame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Secondary outcomes:
measure: Influencing factors of clinical outcomes
timeFrame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
measure: Direct medical costs
timeFrame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
measure: effectiveness of combined clostridium butyricum and bifidobacterium powders
timeFrame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
measure: safety evaluation
timeFrame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Children's Hospital Affiliated to Zhejiang University Medical College
state: Zhejiang
Study officials:
References: