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Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales

NCT07707869 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Enterobacteriaceae Infections
  • Carrier State

Interventions

DIETARY_SUPPLEMENT

Probiotic Preparation

Probiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms

DRUG

Conventional 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 & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Principal Investigators

  • RONG ZHANG · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707869 on ClinicalTrials.gov