Pilot Study Using Oral Capsule Fecal Microbiota Transplant To Decolonize Gastrointestinal Carbapenem-Resistant Enterobacteriaceae (CRE)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant
研究概览
简要总结
Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to carbapenems by producing enzymes that break down carbapenems. The prevalence of CRE continues to rise globally but the treatment options are extremely limited. In case series, isolation of CRE from any site, whether there is clinical infection or not, has been associated with all-cause hospital mortality ranging from 29% to 52%. There are no known methods for reliably decolonizing gastrointestinal (GI) CRE. In rare case reports, fecal microbiota transplant (FMT) has successfully eradicated gastrointestinal colonization of CRE, but there has been no larger study further investigating this. FMT via oral capsules is the least invasive method and has demonstrated efficacy and short-term safety in treating patients with recurrent Clostridium difficile infections. Therefore, the investigators propose this pilot study to determine the effectiveness of oral capsule fecal transplantation in the decolonization of gastrointestinal CRE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient
- •Have intestinal carriage of CRE
排除标准
- •Peripheral WBC >12 x 10^9/L and/or temperature >38 degrees Celsius
- •Swallowing dysfunction or known chronic aspiration
- •Delayed gastric emptying
- •History of intestinal obstruction
- •Active CRE infection
- •Acute exacerbation of underlying comorbid condition
- •Severely immunocompromised patients
- •Inflammatory bowel disease
- •Allergies to ingredients Generally Recognized as Safe
- •Adverse event attributable to previous FMT
- •Concomitant antibiotic use or antibiotic use 48 hours before FMT
研究组 & 干预措施
Oral capsule fecal transplantation
Enrolled patients who have screened positive for CRE in the stool will receive fecal transplant via OpenBiome oral capsules. The patient is given 90 minutes to swallow all capsules and does not require any anesthesia or sedation. Stool samples to test for CRE will be taken 10 days and 30 days after the fecal transplant.
干预措施: Fecal Microbiota Transplantation (Biological)
Observation
Enrolled patients who have screened positive for CRE in the stool will have stool samples to test for CRE taken 10 days and 30 days after initial enrollment.
结局指标
主要结局
Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant
时间窗: 10 days
CRE decolonization is defined by absence of CRE on stool culture using standard clinical laboratory techniques. Stool samples will be collected 10 days after FMT.
Proportion of participants with an adverse event through day 10 (+/- 3 days) after FMT
时间窗: 10 days
Telephone calls are made to participants 10 days after FMT to assess for adverse event, severe adverse event, and adverse events of special interest (newly acquired transmissible infectious diseases).
次要结局
- Proportion of participants with a severe adverse event at month 6 (+/-14 days) after FMT.(6 months)
- Proportion of participants with CRE infection at day 10 (+/-3 days) and month 1 (+/-5 days) after FMT(1 month)
- Proportion of participants with CRE decolonization at month 1 (+/-5 days) after FMT(1 month)
- Proportion of participants with an adverse event, severe adverse event, or adverse events of special interest through month 1 (+/-5 days) after FMT.(1 month)
- Proportion of participants with microbial engraftment assessed by microbiome disruption index (MDI) (MDI-community and MDI-species) measured by 16s ribosomal RNA at time of enrollment, day 10 (+/-3 days) and month 1 (+/-5 days) after FMT(1 month)