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.

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