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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Severance Hospital
Seoul, South Korea
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
Time frame: From enrollment to the end of treatment at 8 weeks
Time to decolonization in the treatment and control groups after completion of BM111 administration
Time to decolonization(day) after completion of BM111 administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: From enrollment to the end of treatment at 8 weeks