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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Probiotic Adjunctive Therapy Group |
|
| Control group | Active Comparator | Conventional Antibiotic Therapy Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Preparation | Dietary Supplement | Probiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RONG ZHANG | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China | ||
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| Conventional Antibiotic | Drug | 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 |
| China |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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