COMPLETED

Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Quick Facts

Study Start:2023-05-01
Study Completion:2024-03-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05826418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Informed consent
  2. * 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)
  3. * Ability to comply with study requirements
  4. * Age at least 18 years old
  1. * Underlying IBD
  2. * History of stomach surgery or bowel resection
  3. * Anticipated antibiotic exposure during the study period
  4. * Advanced liver disease
  5. * Ongoing alcohol or drug abuse
  6. * Pregnancy
  7. * Any reason felt by the investigator to complicate the feasibility of participation

Contacts and Locations

Principal Investigator

Alexander Khoruts, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Alexander Khoruts, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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

Study Start Date2023-05-01
Study Completion Date2024-03-12

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2024-03-12

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Clostridium Difficile Infection
  • Fecal Microbiota Transplant