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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Participants will be asked to adhere to their randomized MEND diet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.
Participants will be asked to adhere to their randomized mNICEdiet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.
University of Minnesota
Minneapolis, Minnesota, United States
Participant acceptance of the diet
Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.
Time frame: 4 weeks
Participant compliance with study procedures
24-hr dietary recalls will be used to assure adherence with the study diet
Time frame: intervention to 4 weeks
Bacterial diversity
Shannon diversity index
Time frame: 1 week
Bacterial diversity
Shannon diversity index
Time frame: 4 weeks
Bacterial diversity
Shannon diversity index
Time frame: 3 months
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Time frame: 1 week
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Time frame: 4 weeks
Similarity to donor bacterial composition
Using SourceTracker
Time frame: 3 months
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time frame: 1 week
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time frame: 4 weeks
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Time frame: 3 months
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