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Clinical Trials/NCT06356545
NCT06356545
Recruiting
Not Applicable

A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China

Children's Hospital of Fudan University1 site in 1 country60 target enrollmentStarted: April 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Clinical phenotype of congenital diarrhea and enteropathy in China

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
1 Month to 3 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Clinical phenotype of congenital diarrhea and enteropathy in China

Time Frame: Within approximately 2 years of enrollment

Describe the clinical phenotype(Birth status, family history, clinical features of diarrhea, laboratory examination, endoscopic and histological evaluation results, growth and development indicators, previous treatment and effect were collected) of congenital diarrhea and enteropathy in China,We will use our own mobile application or to collect the relevant data, which will be filled in by the parents of the child.

Secondary Outcomes

  • Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning(Within approximately 30 months of enrollment)
  • Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features(Within approximately 2 years of enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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