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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-3
SponsorChildren's Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Case
Group B: Control

Trial outcomes

Primary outcomes

1

Clinical phenotype of congenital diarrhea and enteropathy in China

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.

Time frame
Within approximately 2 years of enrollment

Secondary outcomes

1

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

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.

Time frame
Within approximately 2 years of enrollment
2

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

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

Time frame
Within approximately 30 months of enrollment

Other outcomes

Sponsors and contacts

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