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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
Nebraska
Unversity of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Jayson Henrickson, MS
jayson.henrickson@unmc.edu
402-559-3810
Backup
Taylor A Johnson, BS, MA
taylora.johnson@unmc.edu
402-559-0963
Time Frame
Start Date: 2022-04-13
Estimated Completion Date: 2026-07
Participants
Target number of participants: 30
Treatments
Experimental: Treatment
resistant starch
Placebo_comparator: Placebo
maltodextrin
Authors
Christopher D'Angelo
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov