Actively Recruiting
Retrospective Study of Risk Factors and Gut Microbiome Changes in Infant Clostridioides difficile Infection
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) is an increasing concern for the health of infants and young children, with rising detection rates each year. This retrospective study focuses on children aged 0 to 2 years and aims to investigate the epidemiology, clinical signs, and potential biomarkers of CDI by examining three groups: infants diagnosed with CDI, asymptomatic carriers of C. difficile, and healthy controls. The research seeks to identify key risk factors, understand the disease mechanisms, and aid in developing early diagnosis and prevention methods. The study involves collecting and analyzing fecal samples from all three groups. These samples will undergo detailed metagenomic sequencing and metabolomic profiling to explore microbiome changes. Additionally, questionnaire surveys will gather information on potential risk factors. The study uses medical records and stool sample tests collected retrospectively between July 2024 and December 2026. Participants' involvement includes providing access to their medical records and stool samples for analysis. Researchers will review data to determine the prevalence of CDI and asymptomatic carriage during the study period. The study will assess clinical and microbiological information, along with questionnaire responses, to evaluate risk factors and disease patterns. Safety monitoring and long-term participant follow-up are not specified, as this is a retrospective analysis.
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
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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
L
Liqian Wang
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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