Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDI Patients | This group includes infants aged 0-2 years who have been diagnosed with Clostridioides difficile infection (CDI). Diagnosis is based on clinical symptoms such as diarrhea, abdominal pain, or fever, along with positive laboratory confirmation (e.g., stool PCR or culture for C. difficile). | ||
| Asymptomatic Clostridioides difficile Carriers | This group includes infants aged 0-2 years who are colonized with Clostridioides difficile but show no clinical symptoms of infection. Participants in this group tested positive for C. difficile in fecal samples collected during routine or study-related screening. | ||
| Healthy Infants | This group includes infants aged 0-2 years who do not show any clinical symptoms of infection and have tested negative for Clostridioides difficile in fecal samples. Participants were recruited from general pediatric clinics or community health programs. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants | The prevalence of CDI and asymptomatic C. difficile carriage will be determined by testing fecal samples for C. difficile using PCR and/or culture methods. Participants are categorized into three groups based on clinical symptoms (diarrhea, abdominal pain, or fever) and laboratory confirmation (positive PCR or stool culture). Specifically, the primary outcome assesses:
| Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls | Metagenomic sequencing will be performed on fecal samples to assess alpha and beta diversity.The goal is to compare microbial community shifts and identify specific taxa changes associated with CDI. | Same retrospective collection period (2024-2026) |
Not provided
Inclusion Criteria:
Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
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.
Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.
Exclusion Criteria:
Not provided
Not provided
This retrospective observational study will include infants aged 0 to 2 years who underwent clinical evaluation and stool testing for Clostridioides difficile at [Hospital(s)/Institution(s)/Region]. The study population is divided into three groups:
All participants included in this analysis will have relevant medical records and stool sample data available within the study's retrospective timeframe. Additional questionnaire data may be collected from parents or guardians to assess potential risk factors and environmental exposures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Tao, PHD | Contact | 86-19817412816 | taoliang@westlake.edu.cn | |
| Liqian Wang | Contact | 86-18768156110 | wanglq921206@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided