Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-28 @ 7:00 AM
Study NCT ID:
NCT06788769
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Clostridioides Difficile in Infants
Sponsor:
Westlake University
Organization:
Study Overview
Official Title:
Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy controls. Fecal samples from each group will undergo metagenomic sequencing and metabolomic profiling, coupled with questionnaire-based surveys for risk factor assessment. The findings are anticipated to identify key high-risk factors, elucidate the pathogenic mechanisms underlying infant CDI, and support the development of early diagnostic tools and preventive strategies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: