Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

Description

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.

Conditions

Multiple Myeloma, Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Omaha

Unversity of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Willing to provide informed consent
  • 2. Willing to comply with all study procedures and be available for the duration of the study
  • 3. 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)
  • 4. Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
  • 5. Adult Individuals (male or female) at least 19 years of age
  • 6. Meeting indications and recommended for first autologous stem cell transplantation by investigator
  • 1. 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
  • 2. Previous intolerance to fiber supplementation
  • 3. Allergy or intolerance to potato starch or maltodextrin
  • 4. Subject unwilling to comply with stool sample collection
  • 5. Not suitable for study participation due to other reasons at the discretion of the investigators

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Nebraska,

Christopher R D'Angelo, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

2026-07