Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
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.
Conditions:
🦠 Recurrent Clostridium Difficile Infection 🦠 Fecal Microbiota Transplant
🗓️ Study Start (Actual) 1 May 2023
🗓️ Primary Completion (Estimated) 1 August 2025
✅ Study Completion (Estimated) 1 August 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 March 2023
  • First Submitted that Met QC Criteria 20 April 2023
  • First Posted 24 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 September 2023
  • Last Update Posted 21 September 2023
  • Last Verified September 2023