CRE Colonization, VRE Colonization
Conditions
Keywords
Carbapenem-resistant Enterobacteriaceae, Vancomycin-resistant Enterococcus, Decolonization
Brief 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.
Interventions
DIETARY_SUPPLEMENTBM111
A mixture of four intestinal microorganisms
DIETARY_SUPPLEMENTPlacebo
Placebo; Maltodextrin
Sponsors
BioMe Inc.
Severance Hospital
Neonutra
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration | From enrollment to the end of treatment at 8 weeks | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to decolonization in the treatment and control groups after completion of BM111 administration | From enrollment to the end of treatment at 8 weeks | Time to decolonization(day) after completion of BM111 administration |
| Changes in microbiome characteristics (e.g., diversity, microbial composition) in the treatment and control groups after completion of BM111 administration | From enrollment to the end of treatment at 8 weeks | Analysis data on changes in microbial community characteristics (e.g., diversity, microbial composition) for each subject |
| 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 | Reduction rate(%) of CRE/VRE CFU per gram of stool after completion of BM111 administration |
| Decolonization rate at Week 1, Week 4, and Week 8 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 |
| Cumulative engraftment rate of BM111 effective strains | From enrollment to the end of treatment at 8 weeks | Cumulative engraftment rate(%) of 4 effective strains in BM111 |
| Recurrence rate in subjects who achieved successful decolonization after completion of BM111 administration | From enrollment to the end of treatment at 8 weeks | Recurrence rate(%) in subjects who achieved successful decolonization after completion of BM111 administration |
Countries
South Korea
Outcome results
None listed