Exploring Clostridioides Difficile Infections in Infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Liang Tao, PHD
• Email: taoliang@westlake.edu.cn
• Phone: 86-19817412816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics

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• UDCA added to standard therapy to prevent C. diff recurrence

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.