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Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation
Sponsor: University of Nebraska
Summary
Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.
Official title: A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation in Multiple Myeloma and Lymphoma: The PRIMAL Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2022-04-13
Completion Date
2028-07
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Resistant Starch
A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
Maltodextrin
A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed
Locations (1)
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States