VRE ColonizationNCT07525089
Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)
A study testing BM111 in people with VRE Colonization and CRE Colonization, run by BioMe Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- VRE Colonization, CRE Colonization
- What is being tested?
- BM111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- VRE Colonization, CRE Colonization
- Being tested
- BM111, Placebo
- Keywords
- Carbapenem-resistant Enterobacteriaceae, Vancomycin-resistant Enterococcus, Decolonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM111Dietary supplement
A mixture of four intestinal microorganisms
PlaceboDietary supplement
Placebo; Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| BM111 | Experimental | Not described Receives: Dietary Supplement: BM111 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Time to decolonization in the treatment and control groups after completion of BM111 administration
Time to decolonization(day) after completion of BM111 administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start23 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VRE ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Neonutra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525089
- Sponsor's protocol ID
- BioMe_BM111
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07525089
- Acronym / sponsor ID
- BioMe_BM111
- Conditions
- VRE Colonization, CRE Colonization
- Keywords
- Carbapenem-resistant Enterobacteriaceae, Vancomycin-resistant Enterococcus, Decolonization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- BioMe Inc.Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Neonutra
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM111 | Experimental | Dietary Supplement: BM111 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (31 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM111A mixture of four intestinal microorganisms | Dietary supplement | BM111 |
| PlaceboPlacebo; Maltodextrin | Dietary supplement | Placebo |
Primary outcome
Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration
Time frame: 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
6 secondary outcomes
Time to decolonization in the treatment and control groups 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
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
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
Time frame: From enrollment to the end of treatment at 8 weeks
Cumulative engraftment rate of BM111 effective strains
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
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BM111 in people with VRE Colonization and CRE Colonization, run by BioMe Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.