RecruitingNot ApplicableNCT04528303

Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty

A Randomized, Controlled Trial of the Effectiveness of Whole Genome Sequencing Versus Whole Exome Sequencing for Screening Patients With Congenital Diarrhea and Enteropathy (CODESeq)


Sponsor

Children's Hospital of Fudan University

Enrollment

180 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will seek to determine if whole genome sequencing (WGS) improves diagnostic rates, and outcomes for congenital diarrhea and enteropathy (CODE) patients. The investigator will enroll 180 patients in a randomized controlled study to either WGS or whole exome sequencing (WES). This study is designed to evaluate whether CODE patients would benefit from WGS guided precision medicine.


Eligibility

Max Age: 6 Years

Inclusion Criteria3

  • Patients with chronic diarrhea lasting greater than 2 months
  • Patients with consent from parents or legal guardians
  • Biological relative of a patient enrolled in this study.

Exclusion Criteria5

  • Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
  • Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
  • Functional diarrhea
  • Patients with previously confirmed monogenic diarrhea
  • Patients with poor compliance

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICWhole genome sequencing

Genomic sequencing and molecular diagnostic results

GENETICWhole exome sequencing

Genomic sequencing and molecular diagnostic results


Locations(1)

Ying Huang

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04528303


Related Trials