An interventional study of Whole genome sequencing and Whole exome sequencing in Diarrhea, Infantile and Enteropathy, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Diagnostic
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.
24 studies on the registry are indexed under Diarrhea, Infantile; 5 are open to participants now.
This study's planned enrollment of 180 is close to the median of 198 across 17 interventional studies indexed under Diarrhea, Infantile.
Browse Diarrhea, Infantile studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Genetic: Whole genome sequencing
Genetic: Whole exome sequencing
Genomic sequencing and molecular diagnostic results
Genomic sequencing and molecular diagnostic results
Diagnostic rates between WGS and WES
Diagnostic rate of genome and exome based on rate of clinically confirmed diagnoses.
Time frame: Within approximately 60 days of enrollment
Number of patients receiving precision medicine guided by sequencing results
Rate of application of precision medicine suggested by the results of WGS or WES.
Time frame: Within approximately 60 days of enrollment
Mortality of patients
Mortality of patients after WGS and WES
Time frame: Within approximately 1 year of enrollment
Rate of parental satisfaction with sequencing
Parental satisfaction with decision to pursue sequencing based on questionnaire survey
Time frame: Within one week of patient enrollment
Number of parents who are available for trio sequencing
Number of subjects in which both parents are available for trio sequencing
Time frame: Within one week of patient enrollment
Plan to share: No
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Children's Hospital of Fudan University