NCT04593368Unknown2 期
Prospective Non-randomized Phase II Clinical Trial of Safety and Efficacy of Fecal Microbiome Transplantation for Pediatric Patients 3-18 Years Old With Confirmed Colonization With Antibiotic-resistant Bacterias and Indication for Allogeneic Hematopoietic Stem Cell Transplantation
Federal Research Institute of Pediatric Hematology, Oncology and Immunology6 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年12月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Effectiveness
研究概览
简要总结
a clinical trial designed to prospectively assess the safety and effectiveness of fecal microbiota transplantation (FMT) prior to allogeneic hematopoietic stem-cell translation (HSCT) in patients contaminated with antibiotic-resistant pathogens (ARP)
详细描述
The investigator's question is whether FMT decontaminates ARP and as a result, decreases the risk of severe infection which leads to transplant-related morbidity and mortality after HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •detection by microbiology culture in any localization species of:
- •Pseudomonas aeruginosa
- •Clostridium difficile
- •Vancomycin-resistant Enterococcus
- •Streptococcus viridans
- •ESBL Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae
- •Stenotrophomonas maltophilia
- •Acinetobacter
- •Methicillin-resistant Staphylococcus aureus
- •Indications for allo-HSCT
排除标准
- •indications for therapy with antibiotics for the next 7 days after FMT
- •Nonstable condition during 1 week before FMT
- •Therapy with antibiotics less than 48 hours before FMT
- •Age less than 3 years
- •Neutrophils count < 0,5 K/mcL at FMT day and\or predicted decrease during 2 days after Donors (healthy volunteers)
- •Inclusion Criteria:
- •Age 3-50 years old
- •Donor choosing order in the absence of contraindications:
- •HLA-match/mismatch HSCT family donor; 2) Closest family relative with whom the recipient lives; 3) Unrelated healthy volunteer from the FRCC PCM bank of frozen transplants
- •Exclusion Criteria:
- •Presens of:
- •ESBL Esherihia coli
- •Klebsiella pneumoniae
- •Pseudomonas aeruginosa
- •Clostridium difficile
- •Streptococcus viridans
- •ESBL Enterobacteriaceae
- •Stenotrophomonas maltophilia
- •Acinetobacter in feces by microbiology culture assay
- •Therapy with antibiotics less than 3 months before donation
- •Any infection disease revealed during the screening
- •Latent period of infection disease according to the questionnaire
- •Gut disease
- •Longitudinal treatment with drugs
- •Any diet for 3 months before donation.
- •Obesity (BMI ≥ 30).
结局指标
主要结局
Effectiveness
时间窗: 7 days after FMT
frequency of decolonization
frequency of SAEs
时间窗: 1 month after FMT
frequency of SAEs due to FMT
次要结局
- Decolonization(30 days after FMT)
- acute gut GVHD CI(100 days after HSCT)
- Toxicity frequency(7 days after FMT)
- Bacteremia(100 days after FMT)
- Translocation(1 year)
研究者
研究点 (6)
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