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

NCT07707869 | Active Not Recruiting

• 1 other identifier: 2026-0263
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Enterobacteriaceae Infections; Carrier State

Keywords

Probiotics; Enterobacterales infection

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Probiotic Adjunctive Therapy Group

Dietary Supplement: Probiotic Preparation; Drug: Conventional Antibiotic

Control group

ACTIVE COMPARATOR

Conventional Antibiotic Therapy Group

Drug: Conventional Antibiotic

Interventions

Probiotic Preparation DIETARY_SUPPLEMENT

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

Experimental Group

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

Control group; Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory-confirmed intestinal colonization of carbapenem-resistant Enterobacterales, primarily carbapenem-resistant Escherichia coli and Salmonella spp., based on stool culture or rectal swab.
• 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.
• Able and willing to receive the assigned treatment regimen (either standard antibiotic therapy alone or with adjunctive probiotics) as per the study protocol.

You may not qualify if:

• 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.
• Pregnancy or breastfeeding at the time of screening or during the study period.
• 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.
• Immunocompromised status, including but not limited to active chemotherapy, radiotherapy, solid organ transplantation, hematopoietic stem cell transplantation, or long-term use of immunosuppressive agents.
• 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.
• 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.
• Inability or unwillingness to comply with the study visit schedule or other protocol requirements.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• RONG ZHANG

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-02

Locations

CN (2)