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

A Stratified, Randomized, Double-Blind, Placebo-Controlled Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: VRE Colonization; CRE Colonization
• Intervention / Treatment: Dietary supplement: BM111; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03722
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• Subjects with comorbidities that may pose risks during endoscopy or colonoscopy
• Severely immunocompromised subjects
• Subjects receiving high-dose immunosuppressants (e.g., glucocorticoids, azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, mycophenolate mofetil)(Participation may be allowed if deemed not to affect study outcomes by the investigator after review of dose, drug, and duration)
• Subjects requiring antibiotic or related treatment due to severe infection, or planning to use antibiotics during the study period
• Subjects who have taken gastric acid suppressants (e.g., PPIs), antibiotics, antidiarrheal agents, probiotics, prebiotics, or lactic acid bacteria products (≥4 times per week) within 1 week prior to Visit 1
• Subjects with BMI <17 kg/m² at Visit 1

• Subjects with clinically significant abnormal laboratory findings:

  • Hemoglobin (Hb) < 8.0 g/dL ② Platelet count (PLT) < 75,000/mm³

    • AST or ALT ≥3× the upper limit of normal (ULN)

      • Total bilirubin >2× ULN ⑤ Albumin <3.2 mg/dL ⑥ Serum creatinine >2× ULN ⑦ HbA1c >8.0%
• Subjects with a life expectancy of less than 6 months
• Subjects unwilling or unable to use adequate contraception during the study period; Acceptable contraception methods include: intrauterine device (IUD/IUS), sterilization (vasectomy or tubal ligation), or dual barrier methods (e.g., cervical cap or diaphragm with male condom)
• Pregnant or breastfeeding women, or those planning pregnancy during the study period
• Subjects who participated in another interventional clinical trial within 3 months prior to Visit 1, or plan to participate in another interventional clinical trial during this study
• Subjects with hypersensitivity or allergy to food components or investigational product (IP) components
• Subjects deemed unsuitable for participation by the investigator for any other reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo; Maltodextrin
Experimental: BM111	Dietary supplement: BM111; A mixture of four intestinal microorganisms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to decolonization in the treatment and control groups after completion of BM111 administration	Time to decolonization(day) 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	Analysis data on changes in microbial community characteristics (e.g., diversity, microbial composition) for each subject	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	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	Decolonization rate(%) at Week 1, Week 4, and Week 8	From enrollment to the end of treatment at 8 weeks
Cumulative engraftment rate of BM111 effective strains	Cumulative engraftment rate(%) of 4 effective strains in BM111	From enrollment to the end of treatment at 8 weeks
Recurrence rate in subjects who achieved successful decolonization after completion of BM111 administration	Recurrence rate(%) in subjects who achieved successful decolonization after completion of BM111 administration	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation variables - Adverse events	Cases and number of adverse effect	From enrollment to the end of treatment at 8 weeks
Safety evaluation variables - Clinical laboratory tests	Results and values of clinical laboratory tests (hematology, blood chemistry, and urinalysis)	From enrollment to the end of treatment at 8 weeks
Safety evaluation variables - Vital signs	Identifying adverse events in vital signs (blood pressure, pulse, body temperature) and physical measurements (body weight)	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: BioMe Inc.
• Collaborators: Severance Hospital; Neonutra

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Decolonization; Carbapenem-resistant Enterobacteriaceae; Vancomycin-resistant Enterococcus
• Other Study ID Numbers: BioMe_BM111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No