Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy (NCT05135351) | Clinical Trial Compass
RecruitingNot Applicable
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
United States30 participantsStarted 2022-06-07
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Percentage of subjects who adhere to >70% of scheduled doses of the intervention