To evaluate the efficacy of probiotic preparations as adjunctive therapy for the decolonization of intestinal carbapenem-resistant organisms (CRO), in comparison with conventional antibiotic therapy alone, with the primary endpoints including: (1) the clearance rate of intestinal CRO, defined as negative culture for carbapenem-resistant organisms, and (2) the safety assessment of the treatment, through the documentation of adverse events and potential side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Probiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms
Physician-selected antibiotic regimen based on antimicrobial susceptibility testing and clinical indication, administered intravenously or orally at standard therapeutic doses per local antimicrobial stewardship guidelines. Duration ranges from 7 to 14 days depending on clinical response
Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Clearance Rate of Intestinal CRO
Proportion of participants with negative CRO culture from stool samples and negative carbapenemase colloidal gold test at the specified time points. Microbial clearance is defined as the conversion from CRO-positive at baseline to CRO-negative at the assessment visit. The reduction in CRO relative abundance, as measured by fecal metagenomic sequencing, will also be evaluated as a secondary microbiological indicator of clearance.
Time frame: Baseline (pre-treatment), during treatment at 1 week, at end of treatment (2 weeks), and at 1 month post-treatment follow-up for recurrence assessment.
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