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Recruiting NCT06788769

Study of Clostridioides Difficile in Infants

— Observational Clostridioides Difficile Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Clostridioides Difficile Infection. Basic parameters: 1 Day — 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection

Overview

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.

Primary outcome measures

  • Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants [Time frame: Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026.]
Secondary outcome measures (1)
  • Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls [Time frame: Same retrospective collection period (2024-2026)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hangzhou First People's Hospital — Hangzhou

Identifiers

NCT: NCT06788769 · 20241202TL001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗