RecruitingNot ApplicableNCT05135351

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

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


Sponsor

University of Nebraska

Enrollment

30 participants

Start Date

Jun 7, 2022

Study Type

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking prebiotic supplements (which feed beneficial gut bacteria) after a stem cell transplant can restore healthy gut bacteria diversity, which is often disrupted by the transplant process. **You may be eligible if...** - You are willing to provide informed consent and follow study procedures - You have been diagnosed with multiple myeloma, non-Hodgkin lymphoma (certain types), or Hodgkin lymphoma - You are scheduled for an autologous stem cell transplant (using your own stem cells) **You may NOT be eligible if...** - You are not undergoing an autologous stem cell transplant - Your diagnosis does not match the study's eligible cancer types Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTResistant Starch

A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.

DIETARY_SUPPLEMENTMaltodextrin

A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed


Locations(1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT05135351


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