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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06356545
Enrollment
60
Registered
2024-04-10
Start date
2024-04-15
Completion date
2026-10-31
Last updated
2025-09-10

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

Conditions

Diarrhea Infantile

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.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Clinical phenotype of congenital diarrhea and enteropathy in ChinaWithin approximately 2 years of enrollmentDescribe 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

MeasureTime frameDescription
Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome featuresWithin approximately 2 years of enrollmentPlasma 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.
Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learningWithin approximately 30 months of enrollmentUsing 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

Countries

China

Contacts

Primary ContactYing Huang, MD,PHD
yhuang815@163.com+862164931727
Backup ContactYanqiu Wang, MD
23111240040@m.fudan.edu.cn+862164931727

Outcome results

None listed

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