Exploring Clostridioides Difficile Infections in Infants
Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
This study looks at Clostridioides difficile infections in babies under 2 years old to see how it affects them and what might put them at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 1 Day to 2 Years |
| Sex | All |
| Sponsor | Westlake University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06788769 on ClinicalTrials.gov |
What this trial studies
This observational study investigates Clostridioides difficile infections (CDI) in infants aged 0-2 years by analyzing three groups: those diagnosed with CDI, asymptomatic carriers, and healthy controls. Researchers will collect fecal samples for metagenomic sequencing and metabolomic profiling, alongside surveys to assess risk factors. The goal is to identify high-risk factors and understand the pathogenic mechanisms of CDI in infants, which may lead to improved diagnostic tools and preventive strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 0 to 2 years who have either been diagnosed with CDI, are asymptomatic carriers, or are healthy controls.
Not a fit: Patients who are older than 2 years or do not have a documented history of CDI or related gastrointestinal symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early diagnosis and prevention of CDI in infants, potentially reducing morbidity associated with this infection.
How similar studies have performed: While there is ongoing research into CDI, this specific observational approach focusing on infants is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: 1. Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results. 2. Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing. 3. Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Where this trial is running
Hangzhou, Zhejiang
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Liang Tao, PHD
- Email: taoliang@westlake.edu.cn
- Phone: 86-19817412816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.