Actively Recruiting
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
Led by University of Nebraska · Updated on 2026-04-20
30
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma per standard of care
- Meeting standard-of-care indication for autologous stem cell transplantation or recommended for CAR-T cell therapy as determined by investigator
- Adult male or female at least 19 years of age
You will not qualify if you...
- History of bariatric surgery such as gastric banding, sleeve gastrectomy, or 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, resistant starch, or maltodextrin
- Unwillingness to comply with stool sample collection
- Any other reasons that make participation unsuitable as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
J
Jayson Henrickson, MS
CONTACT
T
Taylor A Johnson, BS, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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