🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Study of Clostridioides Difficile in Infants

Recruitingn/aAges 1 Day - 2 YearsAllWestlake University
NCT06788769 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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.
💊

What it tests

  • Not listed
📍

Where

1 site
Hangzhou First People's Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy