Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diarrhea Infantile. Basic parameters: 1 months — 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Overview
This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.
Detailed description
This study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (CODE), The investigator will mine biomarkers of CODE through multi-omics technology. This study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.
Primary outcome measures
- Clinical phenotype of congenital diarrhea and enteropathy in China [Time frame: Within approximately 2 years of enrollment]
Secondary outcome measures (2)
- Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features [Time frame: Within approximately 2 years of enrollment]
- Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning [Time frame: Within approximately 30 months of enrollment]
Eligibility criteria
Inclusion criteria
- Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
- Patients with consent from parents or legal guardians
Exclusion criteria
- Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
- Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
- Functional diarrhea
- Patients with poor compliance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Yanqiu Wang — Shanghai
Identifiers
NCT: NCT06356545 · OMICS_CODE_01