Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation
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
University of Nebraska
30 participants
Apr 13, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Has pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma as determined on medical record review per standard of care transplant procedures (no tissue required for study)
- Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
- Adult Individuals (male or female) at least 19 years of age
- Meeting indications and recommended for first autologous stem cell transplantation by investigator
Exclusion Criteria5
- History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease
- Previous intolerance to fiber supplementation
- Allergy or intolerance to potato starch or maltodextrin
- Subject unwilling to comply with stool sample collection
- Not suitable for study participation due to other reasons at the discretion of the investigators
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Interventions
A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05135351