Multiple Myeloma Clinical Trial
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Eligible for first autologous transplant for myeloma
Willing to adhere to the allowed and disallowed foods of the diet plan.
Able to get and prepare their own food items for all meals during the study
Exclusion Criteria:
Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
Pregnant women, planning to get pregnant or breastfeeding
Prior bowel resection
Inability to tolerate the study diet due to allergies/ intolerance/ preference
Inability to consent to trial
Patients with restrictions in diet including inability to have oral nutrition with regular consistency
Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Patients with absolute neutrophil count (ANC) < 1000 on long term antibacterial prophylaxis ongoing 3 days prior to enrollment
Patients who received antifungal therapy in 3 days prior to enrollment
Patients who received steroid therapy in 7 days prior to enrollment
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There is 1 Location for this study
Cleveland Ohio, 44106, United States More Info
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Principal Investigator
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