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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Willing to provide willing to sign a consent form 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

Resistant 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_SUPPLEMENT

Maltodextrin

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