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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: VRE Colonization, CRE Colonization

In brief

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

Key facts

Study ID

NCT07525089

Run by

BioMe Inc.

People needed

38

Starts

2026-03-23

Expected to finish

2027-02-20

Last updated by the study team

2026-04-13

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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%

Where it is running

• Severance Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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