Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy

Recruiting

A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy in Multiple Myeloma and Lymphoma: The PRIMAL Trial

Who can join

Ages 19 and older · All sexes

Full eligibility criteria

Inclusion 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

Exclusion Criteria:

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

Eligibility Criteria for CAR T-cell Therapy Cohort

Inclusion 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 lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy
4. Adult Individuals (male or female) at least 19 years of age
5. Meeting indications and recommended for CAR-T cell therapy by investigator

Exclusion Criteria:

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, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator
2. Previous intolerance to fiber supplementation
3. Allergy or intolerance to resistant 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

About the study

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.

What is being tested

Resistant Starch (dietary supplement)
Maltodextrin (dietary supplement)

Sponsor: University of Nebraska · Participants: 30 · Started: May 13, 2022

Contact the study team

Jayson Henrickson, MS · Phone: 402-559-3810
Taylor A Johnson, BS, MA · Phone: 402-559-0963

Official record on ClinicalTrials.gov — NCT05135351

Locations in the U.S.

Nebraska

Unversity of Nebraska Medical Center, Omaha

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.