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临床试验/NCT05826418
NCT05826418已完成不适用

Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

University of Minnesota2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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