Fecal Microbiota Transplant, Recurrent Clostridium Difficile Infection
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMEND diet
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.
DIETARY_SUPPLEMENTmNICE 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant compliance with study procedures | intervention to 4 weeks | 24-hr dietary recalls will be used to assure adherence with the study diet |
| Participant acceptance of the diet | 4 weeks | Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial diversity | 1 week | Shannon diversity index |
| Similarity to donor bacterial composition | 1 week | Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure |
| Bacterial composition | 1 week | Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence |
Countries
United States
Outcome results
None listed