Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEND diet patients being treated with FMT |
Dietary Supplement: MEND 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.
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| Active Comparator: mNICE (modified NICE) diet patients being treated with FMT |
Dietary Supplement: mNICE 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- Participant compliance with study procedures [intervention to 4 weeks]
24-hr dietary recalls will be used to assure adherence with the study diet
Secondary Outcome Measures
- Bacterial diversity [1 week]
Shannon diversity index
- Bacterial diversity [4 weeks]
Shannon diversity index
- Bacterial diversity [3 months]
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
- Similarity to donor bacterial composition [4 weeks]
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
- Similarity to donor bacterial composition [3 months]
Using SourceTracker
- Bacterial composition [1 week]
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
- Bacterial composition [4 weeks]
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
- Bacterial composition [3 months]
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent
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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)
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Ability to comply with study requirements
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Age at least 18 years old
Exclusion Criteria:
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Underlying IBD
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History of stomach surgery or bowel resection
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Anticipated antibiotic exposure during the study period
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Advanced liver disease
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Ongoing alcohol or drug abuse
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Pregnancy
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Any reason felt by the investigator to complicate the feasibility of participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55414 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Alexander Khoruts, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rCDI