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The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.
This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycobiome Supporting Diet | Experimental | Participants will be able to abide by the allowed and disallowed foods in MSD diet for at least four consecutive weeks prior to conditioning and up to 10 days after transplant. Participants will maintain a diary of foods they consume and any adverse effects they are experiencing and will self- collect fecal samples 28 days before transplant, 2 days before transplant and 10 days after transplant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycobiome Supporting Diet | Behavioral | MSD takes combines elements from several diets (e.g., Paleo, low-carbohydrate, vegetarian, and Mediterranean) and excludes elements of these diets that have been specifically proven to increase pathogenic fungi in the human gut. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire | MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time". | 21 days prior to Transplant (an average of 1 month from start of study) |
| Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire | MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time". | 14 days prior to transplant (an average of 1 month from start of study) |
| Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire | MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehsan Malek, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
IPD will not be shared due to the small sample size of the study participants in order to protect their identities.
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 7 days prior to transplant (an average of 1 month from start of study) |
| Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire | Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less | After baseline (7 days post-transplant) |
| PRO-CTCAE questionnaire scores | Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less | week 1 in the 1 month prior to transplant |
| PRO-CTCAE questionnaire scores | Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less | week 2 in the 1 month prior to transplant |
| PRO-CTCAE questionnaire scores | Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less | week 3 in the 1 month prior to transplant |
| PRO-CTCAE questionnaire scores | Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less | week 4 in the 1 month prior to transplant |