Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Study Overview
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Brief Summary
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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
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Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Conditions
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Recurrent Clostridium Difficile Infection, Fecal Microbiota Transplant

Intervention / Treatment
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* Dietary Supplement: MEND diet
* Dietary Supplement: mNICE diet


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEND diet<br>patients being treated with FMT | Dietary Supplement: MEND diet<br>* 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.<br>|
| Active Comparator: mNICE (modified NICE) diet<br>patients being treated with FMT | Dietary Supplement: mNICE diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 
| Participant compliance with study procedures | 24-hr dietary recalls will be used to assure adherence with the study diet | intervention to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial diversity | Shannon diversity index | 1 week | 
| Bacterial diversity | Shannon diversity index | 4 weeks | 
| Bacterial diversity | Shannon diversity index | 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 | 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 | 4 weeks | 
| Similarity to donor bacterial composition | Using SourceTracker | 3 months | 
| Bacterial composition | Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence | 1 week | 
| Bacterial composition | Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence | 4 weeks | 
| Bacterial composition | Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence | 3 months |