NCT07525089Enrolling By Invitation不适用
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)
BioMe Inc.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年3月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration
研究概览
简要总结
A clinical study to eliminate intestinal colonization in subjects harboring microorganisms resistant to carbapenem and vancomycin antibiotics, thereby treating infections caused by these microorganisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
BM111
Experimental
干预措施: BM111 (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Cumulative decolonization rate in the treatment and control groups after completion of BM111 administration
时间窗: 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
次要结局
- Time to decolonization in the treatment and control groups after completion of BM111 administration(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(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(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(From enrollment to the end of treatment at 8 weeks)
- Cumulative engraftment rate of BM111 effective strains(From enrollment to the end of treatment at 8 weeks)
- Recurrence rate in subjects who achieved successful decolonization after completion of BM111 administration(From enrollment to the end of treatment at 8 weeks)
研究者
研究点 (1)
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