Study of Clostridioides Difficile in Infants

Recruiting now

Conditions studied: Clostridioides Difficile Infection

In brief

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.

Key facts

Study ID

NCT06788769

Run by

Westlake University

People needed

300

Starts

2024-07-01

Expected to finish

2026-12-30

Last updated by the study team

2025-01-23

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
• 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.
• 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 it is running

• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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