Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)

NCT07525089 | Enrolling By Invitation

• 1 other identifier: BioMe_BM111
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study to eliminate intestinal colonization in subjects harboring microorganisms resistant to carbapenem and vancomycin antibiotics, thereby treating infections caused by these microorganisms.

Conditions

CRE Colonization; VRE Colonization

Keywords

Carbapenem-resistant Enterobacteriaceae; Vancomycin-resistant Enterococcus; Decolonization

Outcome Measures

Primary Outcomes (1)

• Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration

  * Decolonization is defined as meeting any of the following criteria: * A reduction of ≥10² CFU (≥99.0%) from baseline, or a reduction from baseline confirmed on two occasions during the study period ② Three consecutive negative results for CRE or VRE detection

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• Time to decolonization in the treatment and control groups after completion of BM111 administration

  From enrollment to the end of treatment at 8 weeks

• Changes in microbiome characteristics (e.g., diversity, microbial composition) in the treatment and control groups after completion of BM111 administration

  From enrollment to the end of treatment at 8 weeks

• Reduction rate of CRE/VRE CFU per gram of stool after completion of BM111 administration

  From enrollment to the end of treatment at 8 weeks

• Decolonization rate at Week 1, Week 4, and Week 8 after completion of BM111 administration

  From enrollment to the end of treatment at 8 weeks

• Cumulative engraftment rate of BM111 effective strains

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (3)

• Safety evaluation variables - Adverse events

  From enrollment to the end of treatment at 8 weeks

• Safety evaluation variables - Clinical laboratory tests

  From enrollment to the end of treatment at 8 weeks

• Safety evaluation variables - Vital signs

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

BM111

EXPERIMENTAL

Dietary Supplement: BM111

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

BM111 DIETARY_SUPPLEMENT

A mixture of four intestinal microorganisms

BM111

Placebo DIETARY_SUPPLEMENT

Placebo; Maltodextrin

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥19 years and \<65 years
• Subjects with confirmed intestinal colonization of Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococcus (VRE) at ≥10⁴ CFU per gram of stool at Visit 1
• Subjects who are carriers of CRE or VRE at Visit 1 and do not require treatment for CRE or VRE infection
• Subjects who are able to read and understand the informed consent document and agree to provide stool samples
• Subjects who voluntarily agree to participate in the study prior to initiation and provide written informed consent (Informed Consent Form)

You may not qualify if:

• Subjects whose CRE or VRE colonization in stool at Visit 2 has decreased by ≥10² CFU per gram compared to Visit 1
• Subjects with the following medical conditions or history:
• History of solid organ transplantation (e.g., heart, kidney, lung)
• Neutropenia
• Septic shock due to systemic inflammatory response syndrome (SIRS) or sepsis with persistent hypotension (systolic blood pressure \<90 mmHg)
• Toxic megacolon or small bowel obstruction
• History of colectomy or colon resection ⑥ History of fecal microbiota transplantation (FMT)
• Epilepsy (seizure disorder), or history of recurrent seizures or cardiac arrest
• Severe anaphylaxis ⑨ Major gastrointestinal surgery (e.g., gastrectomy) within 3 months prior to Visit 1 (Appendectomy or cholecystectomy are allowed) ⑩ History of bacteremia within 2 weeks prior to Visit 1 ⑪ Pitt bacteremia score ≥4
• Subjects currently admitted to the intensive care unit (ICU) or requiring ICU admission due to severe illness
• Subjects requiring mechanical ventilation or vasopressor support (e.g., norepinephrine, ephedrine)
• Subjects receiving active treatment (chemotherapy, radiotherapy, biologic therapy, or maintenance chemotherapy) for active malignancy (including metastatic cancer)
• Subjects requiring treatment for central nervous system infections (e.g., meningitis, encephalitis, shunt infection)
• Subjects undergoing peritoneal dialysis
• Subjects with diarrhea caused by Clostridioides difficile infection

Sponsors & Collaborators

• BioMe Inc.: lead
• Severance Hospital: collaborator
• Neonutra: collaborator

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 13, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

KR (1)