Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistan… (NCT07525089) | Clinical Trial Compass
By InvitationNot Applicable
Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)
South Korea38 participantsStarted 2026-03-23
Plain-language 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.
Who can participate
Age range19 Years – 65 Years
SexALL
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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…
What they're measuring
1
Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration
Timeframe: From enrollment to the end of treatment at 8 weeks