Status:
WITHDRAWN
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Autologous Transplant
Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04685525
Start Date
April 1 2024
End Date
June 30 2025
Last Update
April 26 2024
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106