NCT05135351 · University of Nebraska
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
What this study 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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
Time frame: 35 Days
To understand the feasibility of the intervention in the proposed study population, the percentage of subjects who adhere to \>70% of scheduled doses will be calculated
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Eligibility Criteria for CAR T-cell Therapy Cohort 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 lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy
- Adult Individuals (male or female) at least 19 years of age
- Meeting indications and recommended for CAR-T cell therapy 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, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator
- Previous intolerance to fiber supplementation
- Allergy or intolerance to resistant 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
Where
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations