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

Официальное название

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)

Обзор

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

Вмешательства

• Пищевая добавка BM111
  A mixture of four intestinal microorganisms
• Пищевая добавка Placebo
  Placebo; Maltodextrin

Первичные конечные точки

• Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (6)

• Time to decolonization in the treatment and control groups after completion of BM111 administration [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cumulative engraftment rate of BM111 effective strains [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Recurrence rate in subjects who achieved successful decolonization after completion of BM111 administration [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Severance Hospital — Seoul

Идентификаторы

NCT: NCT07525089 · BioMe_BM111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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