Enterobacteriaceae Infections, Carrier State
Conditions
Keywords
Probiotics, Enterobacterales infection
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic Preparation
Probiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms
DRUGConventional Antibiotic
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
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Laboratory-confirmed intestinal colonization of carbapenem-resistant Enterobacterales, primarily carbapenem-resistant Escherichia coli and Salmonella spp., based on stool culture or rectal swab. 2. Hepatic and renal function within normal limits or with only mild abnormalities, as determined by the investigator, to permit safe administration of the intended treatment. 3. Able and willing to receive the assigned treatment regimen (either standard antibiotic therapy alone or with adjunctive probiotics) as per the study protocol.
Exclusion criteria
1. Known hypersensitivity or allergy to any excipient of the probiotic preparation, including but not limited to milk/whey, lactose, soy, corn starch, maltodextrin, sweeteners, or flavors. 2. Pregnancy or breastfeeding at the time of screening or during the study period. 3. Severe chronic organ dysfunction, including but not limited to cardiac, hepatic, or renal failure, that in the investigator's opinion would compromise patient safety or study outcomes. 4. Immunocompromised status, including but not limited to active chemotherapy, radiotherapy, solid organ transplantation, hematopoietic stem cell transplantation, or long-term use of immunosuppressive agents. 5. Use of concomitant medications that may have serious interactions with the probiotic preparation or that could confound the assessment of the primary outcome, as judged by the investigator. 6. Current participation in another interventional clinical trial, or participation within 30 days prior to screening, or any previous enrollment in a trial that could interfere with the objectives of this study. 7. Inability or unwillingness to comply with the study visit schedule or other protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance Rate of Intestinal CRO | 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. | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORRONG ZHANG
Zhejiang University
Outcome results
None listed