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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEND diet | Experimental | patients being treated with FMT |
|
| mNICE (modified NICE) diet | Active Comparator | patients being treated with FMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEND diet | Dietary Supplement | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial diversity | Shannon diversity index | 1 week |
| Bacterial diversity | Shannon diversity index | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Khoruts, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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|
| mNICE diet | Dietary Supplement | 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. |
|
| 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 |