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

NCT06356545 | Recruiting

• 1 other identifier: OMICS_CODE_01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea Infantile

Outcome Measures

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.

  Within approximately 2 years of enrollment

Secondary Outcomes (2)

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

  Within approximately 2 years of enrollment

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

  Within approximately 30 months of enrollment

Study Arms (2)

Case

Congenital diarrhea and enteropathy (CODE) patients

Control

Healthy children

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Yanqiu Wang

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ying Huang, MD,PHD

CONTACT

+862164931727; yhuang815@163.com

Yanqiu Wang, MD

CONTACT

+862164931727; 23111240040@m.fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 10, 2024
• Study Start: April 15, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)