Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Participant compliance with study procedures
研究概览
简要总结
Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Informed consent
- •Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment)
- •Ability to comply with study requirements
- •Age at least 18 years old
排除标准
- •Underlying IBD
- •History of stomach surgery or bowel resection
- •Anticipated antibiotic exposure during the study period
- •Advanced liver disease
- •Ongoing alcohol or drug abuse
- •Pregnancy
- •Any reason felt by the investigator to complicate the feasibility of participation
结局指标
主要结局
Participant compliance with study procedures
时间窗: intervention to 4 weeks
24-hr dietary recalls will be used to assure adherence with the study diet
Participant acceptance of the diet
时间窗: 4 weeks
Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.
次要结局
- Bacterial composition(3 months)
- Bacterial diversity(3 months)
- Similarity to donor bacterial composition(3 months)
