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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Resistant Starch
  • Maltodextrin

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators