Using prebiotics to enhance gut health after stem cell transplantation
A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy in Multiple Myeloma and Lymphoma: The PRIMAL Trial
This study is testing if taking a prebiotic supplement can help improve gut health in patients with multiple myeloma or lymphoma who are getting stem cell transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT05135351 on ClinicalTrials.gov |
What this trial studies
This study investigates whether prebiotic supplementation with resistant starch can improve gut microbiome diversity in patients undergoing autologous stem cell transplantation for multiple myeloma or lymphoma. Participants will be randomly assigned to receive either resistant starch or a placebo for approximately 10 days prior to stem cell infusion, continuing until the first day of neutrophil engraftment. The primary goal is to assess differences in gut microbiome diversity at the time of engraftment, alongside dietary evaluations and serum sample collection to analyze gut permeability changes during the transplant process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with pathologically confirmed multiple myeloma or lymphoma who are recommended for their first autologous stem cell transplantation.
Not a fit: Patients with a history of bariatric surgery or chronic gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and recovery outcomes for patients undergoing stem cell transplantation.
How similar studies have performed: While this approach is novel in targeting gut microbiome diversity specifically in the context of stem cell transplantation, related studies have shown the importance of gut health in recovery outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Eligibility Criteria for CAR T-cell Therapy Cohort 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 lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy 4. Adult Individuals (male or female) at least 19 years of age 5. Meeting indications and recommended for CAR-T cell therapy 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, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator 2. Previous intolerance to fiber supplementation 3. Allergy or intolerance to resistant 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
Where this trial is running
Omaha, Nebraska
- Unversity of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Christopher R D'Angelo, MD — University of Nebraska
- Study coordinator: Jayson Henrickson, MS
- Email: jayson.henrickson@unmc.edu
- Phone: 402-559-3810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.