Study of Clostridioides Difficile in Infants
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
| Condition(s) | Clostridioides Difficile Infection |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation. 2. Data Availability: Complete medical records or available stool samples within the study's retrospective time frame. 3. Group-Specific Criteria: CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture. Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms. Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI. 4. Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the ins |
| Ages | 1 Day to 2 Years |
| Sex | All |
| Lead sponsor | Westlake University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-07-01 |
| NCT ID | NCT06788769 |
| Official listing | https://clinicaltrials.gov/study/NCT06788769 |