Study on Clostridium Difficile Infection in Infants
ConditionClostridium Difficile Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-24
SponsorFirst People's Hospital of Hangzhou
About this trial
This study aims to investigate the epidemiological characteristics and biomarkers of Clostridium difficile infection in infants . By analyzing historical medical data and patient questionnaires, this retrospective cohort study will identify potential high-risk factors and establish baseline biomarkers to improve diagnosis and treatment for affected patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants ( aged 0-2 years). Medical records and patient questionnaires available with confirmed Clostridium difficile infection (for case group) or without infection (for control group).
Disqualifiers
Infants beyond the age of 2 years at the time of diagnosis. Incomplete medical records or missing essential information related to infection status, feeding methods, or antibiotic exposure.Patients with other severe gastrointestinal conditions that may confound results.
Trial population
Infants diagnosed with Clostridium difficile infection, along with age-matched control subjects without infection, recruited from affiliated hospitals and society. Participants will be selected based on inclusion and exclusion criteria to ensure a representative sample for studying infection risk factors and biomarker discovery in this population
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Case Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Number of Infants With Identified High-Risk Factors for Clostridium difficile Infection (CDI)
This measure reports the number of infants with high-risk factors associated with Clostridium difficile infection (CDI), as assessed by data on feeding methods, antibiotic use, and environmental exposures. Quantitative data will be analyzed to identify correlations and trends.
Time frame
Retrospective data review spanning from initial exposure to Clostridium difficile infection up to 12 months post-diagnosis.Secondary outcomes
1
Number of Identified Biomarkers Associated With Clostridium difficile Infection in Infants
This measure reports the number of specific biomarkers identified from collected biological samples that are associated with Clostridium difficile infection in infants and young children. Biomarkers include bacterial taxa, metabolites, and other biological indicators relevant to infection susceptibility and disease progression. These biomarkers will be analyzed to evaluate their potential roles as risk factors, diagnostic indicators, and predictors of disease outcomes.
Time frame
From the initiation of the study until 12 months after the last sample collection2
Validation of Experimental Mouse Model for Clostridium difficile Infection and Biomarker Identification
This measure involves the validation of an experimental mouse model designed to simulate Clostridium difficile infection and identify key biomarkers associated with infection risk in infants. The validation process includes assessing the mouse model's effectiveness in replicating human disease conditions, such as microbiota composition and immune response. Specific biomarkers, including bacterial taxa, host immune markers, and metabolites, will be analyzed to evaluate the model's relevance for further biomarker discovery and translational research.
Time frame
From the initiation of the study until completion of biomarker identification, approximately 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
First People's Hospital of Hangzhou
Lead sponsor
Westlake University
Collaborator
Source ClinicalTrials.gov