Study of Clostridioides Difficile in Infants

Launched by WESTLAKE UNIVERSITY · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying Clostridioides difficile infection (CDI) in infants, which is becoming a more common health issue for children under two years old. The researchers want to understand how often CDI occurs, what symptoms it causes, and what factors might put infants at risk. To do this, they will look at three groups of children: those who have CDI, those who carry the bacteria without showing symptoms, and healthy children without any infection. The study will use stool samples and surveys to gather information, which will help identify important risk factors and possibly lead to better ways to diagnose and prevent CDI in the future.

To be eligible for the study, infants must be between the ages of 0 and 2 years and have either a confirmed CDI diagnosis, be an asymptomatic carrier of the bacteria, or be healthy with no signs of infection. Parents or guardians will be asked to provide consent for using existing medical records and sample information. Participants can expect to help researchers learn more about CDI, which could lead to new insights into managing this infection in young children.

Gender

ALL

Eligibility 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.