A Monocentric, Prospective, Randomized, Placebo-controlled, Double-blinded Trial Investigating the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Capsules in Decolonization of Patients With Intestinal Carriage of Multidrug-resistant Organisms
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Efficacy (decolonization on visit 7)
研究概览
简要总结
The goal of this clinical trial is to learn if oral capsules containing lyophilized stool from healthy donors (fecal microbiota transplantation or FMT) can safely and effectively decolonize multidrug-resistant organisms (MDROs) from the intestines in adults. The main questions it aims to answer are:
- Does FMT via oral capsules reduce or eliminate intestinal MDRO colonization?
- What side effects or adverse events occur after taking FMT capsules?
Researchers will compare FMT capsules to placebo capsules to see if FMT is effective and safe for decolonizing MDROs.
Participants will:
- Take either FMT capsules or placebo capsules by mouth
- Attend 4 follow-up study visits over 6 months (180 days) for microbiological testing and safety monitoring
- Provide stool samples and report any side effects
详细描述
Antimicrobial resistance (AMR) is a growing global health threat, with multidrug-resistant organisms (MDROs) causing substantial morbidity, mortality, and healthcare costs. Among the most concerning MDROs are extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E), carbapenem-resistant Enterobacterales (CRE), and vancomycin-resistant enterococci (VRE). Colonization of the intestinal tract with these pathogens significantly increases the risk of subsequent invasive infections and facilitates nosocomial transmission, particularly in high-risk populations such as hospitalized or immunocompromised patients.
Current approaches to MDRO decolonization, including selective digestive decontamination and antimicrobial therapy, have shown inconsistent efficacy and carry the risk of further promoting resistance. Therefore, there is an urgent need for novel, non-antibiotic interventions that can effectively reduce intestinal MDRO colonization.
Fecal microbiota transplantation (FMT) has emerged as a promising strategy to restore a healthy gut microbiome and outcompete resistant organisms. While FMT is an established therapy for recurrent Clostridioides difficile infection, its use in MDRO decolonization remains investigational. Most available data come from small cohort studies or case series, with limited evidence from controlled trials.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of FMT using lyophilized stool capsules for the decolonization of intestinal MDROs.
Study Design and Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years,
- •rectal swab positive for MDRO (including but not limited to: CRE, ESBL-E, VRE) within a week of randomization,
- •capable of swallowing oral capsules,
- •willing to give informed consent
排除标准
- •antibiotic treatment on the day of inclusion,
- •pregnant or breastfeeding, women of childbearing potential who are unwilling or unable to use an acceptable method of birth control,
- •patients with terminal diseases with expected life expectancy < 6 months,
- •unwillingness to ingest the capsules,
- •a history of colectomy, present colostomy or ileostomy,
- •patients with the diagnosis/treatment of inflammatory or functional bowel disease,
- •patients with malignant bowel diseases,
- •absolute neutrophil count < 500/mm3,
- •selective digestive decolonization with antibiotics within 6 months before randomization,
- •severe allergy to capsule components
结局指标
主要结局
Efficacy (decolonization on visit 7)
时间窗: Day 180 ± 7 from randomization
Decolonization on day 180 as determined by microbiological analysis. Rectal swabs or stool samples will be collected during each of the scheduled visits. Stool samples are preferred and are self-collected by participants. If stool sample is unavailable, a rectal swab will be collected. The samples will be promptly delivered to the local microbiology laboratory and processed using standard laboratory procedures.
次要结局
- Early decolonization(Day 30 +/- 3 after randomization)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From randomization to day 180 +/-7)
研究者
Igor Rubinić
Prinicpal investigator
University of Rijeka