Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06356545

Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diarrhea Infantile Diarrhea Diarrhea, Infantile Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yanqiu Wang

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Ying Huang

CONTACT

[email protected]

02164931727

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features

    Time frame: Within approximately 2 years of enrollment

    Plasma and stool were collected from patients and healthy control children for multi-omics screening to identify biomarkers, of which differential expression were mined through proteome(olink), microbiome(metagenomic sequencing) and metabolome( untargeted metabolomics)，relevant statistical analyses were performed using non-parametric tests, such as the Wilcoxon signed-rank test.

  2. Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning

    Time frame: Within approximately 30 months of enrollment

    Using artificial intelligence and machine learning to construct predictive models for congenital diarrhea and enteropathy by combining children's clinical phenotypes and multi-omics results，such as the random forest model

Study contacts

Contact information is provided by the study sponsor or research team.

Yanqiu Wang, MD

CONTACT

[email protected]

+862164931727

Ying Huang, MD,PHD

CONTACT

[email protected]

+862164931727

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.