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

  • STATUS
    Recruiting
  • End date
    May 13, 2023
  • participants needed
    30
  • sponsor
    University of Nebraska
Updated on 29 April 2022
lymphoma
multiple myeloma
cell transplantation
stem cell infusion
neutrophil count
follicular lymphoma
mantle cell lymphoma
t-cell lymphoma

Summary

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma, but no strategies have been identified to date that specifically target the gut microbiome. We hypothesize that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment.

To test this hypothesis, we propose a randomized, double-blind, placebo-controlled trial of resistant starch versus placebo (maltodextrin) in patients with myeloma or lymphoma undergoing autologous stem cell transplantation. Thirty subjects will be randomized 1:1 to the RS or placebo arm, dosed at 20g daily for 3 days followed by an increased to 20g twice a day mixed into a food item of the subject's choice. The intervention will begin approximately 10 days prior to stem cell infusion and will continue until the first day of neutrophil engraftment (first day absolute neutrophil count >500) or approximately 30 days in total. Fecal samples will be collected at 4 timepoints for microbiome analysis: 1) at study enrollment 2) day of stem cell infusion 3) day +7 post auto transplant and 4) first day of engraftment defined as absolute neutrophil count >500 (approximately 10-14 days post-transplant).

The primary endpoint will be the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint. Secondary endpoints will include 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.

Details
Condition Multiple Myeloma, Lymphoma
Treatment Maltodextrin, Resistant starch
Clinical Study IdentifierNCT05135351
SponsorUniversity of Nebraska
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Previous intolerance to fiber supplementation
Allergy or intolerance to potato starch or maltodextrin
Subject unwilling to comply with stool sample collection
Not suitable for study participation due to other reasons at the discretion of the investigators
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