NCT06788769 Study of Clostridioides Difficile in Infants
| NCT ID | NCT06788769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Westlake University |
| Condition | Clostridioides Difficile Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-07-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06788769 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 2 Years, studying Clostridioides Difficile Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06788769 currently recruiting?
Yes, NCT06788769 is actively recruiting participants. Contact the research team at taoliang@westlake.edu.cn for enrollment information.
Where is the NCT06788769 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06788769 clinical trial?
NCT06788769 is sponsored by Westlake University. The trial plans to enroll 300 participants.