Study of Clostridioides Difficile in Infants
ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-2
SponsorWestlake University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial population
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: 1. CDI Patients: Infants with laboratory-confirmed C. difficile (PCR or culture) and clinical symptoms consistent with infection (e.g., diarrhea, abdominal pain). 2. Asymptomatic Carriers: Infants who tested positive for C. difficile but did not exhibit any related symptoms. 3. Healthy Controls: Infants who tested negative for C. difficile and had no history of gastrointestinal symptoms during the same period. 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: CDI Patients
Group B: Asymptomatic Clostridioides difficile Carriers
Group C: Healthy Infants
Trial outcomes
Primary outcomes
1
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: 1. The proportion of infants (0-2 years) testing positive for C. difficile who exhibit clinical symptoms (CDI patients). 2. The proportion of infants (0-2 years) testing positive but showing no symptoms (asymptomatic carriers), and the proportion of infants testing negative (healthy controls).
Time frame
Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026.Secondary outcomes
1
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.
Time frame
Same retrospective collection period (2024-2026)Sponsors and contacts
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Source ClinicalTrials.gov