Actively Recruiting
Study of Clostridioides Difficile in Infants
Led by Westlake University · Updated on 2025-01-23
300
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Clostridioides Difficile in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 0 to 2 years at the time of sample collection or medical record documentation
- Complete medical records or available stool samples within the study's retrospective time frame
- For CDI patients: Documented diarrhea or related gastrointestinal symptoms with laboratory-confirmed C. difficile by PCR or culture
- For asymptomatic carriers: Positive C. difficile test by PCR or culture without diarrhea or other clinical CDI symptoms
- For healthy controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI
- Retrospective data may be included under IRB-approved waiver of consent; new information from participants or guardians requires explicit informed consent
You will not qualify if you...
- Incomplete medical records or inadequate stool sample results to confirm CDI status
- Presence of other infectious diseases or conditions that may cause diarrhea without conclusive C. difficile testing
- Severe life-threatening congenital conditions, such as severe immunodeficiency syndromes, that could significantly affect gut microbiota or CDI diagnosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Liang Tao, PHD
CONTACT
L
Liqian Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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