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

NCT ID: NCT06356545

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Diarrhea Infantile

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case

Congenital diarrhea and enteropathy (CODE) patients

No interventions assigned to this group

Control

Healthy children

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yanqiu Wang

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Huang, MD,PHD

Role: CONTACT

+862164931727

Yanqiu Wang, MD

Role: CONTACT

+862164931727

Facility Contacts

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Ying Huang

Role: primary

02164931727

Other Identifiers

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OMICS_CODE_01

Identifier Type: -

Identifier Source: org_study_id

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