NCT05135351Recruiting
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Nov 2021
- Start date
- 13 May 2022
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Nebraska
- Diseases
- Multiple myeloma
- NCT number
- NCT05135351
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 13 May 2022 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intolerance to fiber supplementation
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Eligibility Criteria for CAR T-cell Therapy Cohort
- Previous intolerance to fiber supplementation
Other illness
- 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
- Allergy or intolerance to potato starch or maltodextrin
- 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
- Allergy or intolerance to resistant starch or maltodextrin
Other
- Subject unwilling to comply with stool sample collection
- Subject unwilling to comply with stool sample collection
- Not suitable for study participation due to other reasons at the discretion of the investigators
Who the study is looking for
- 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
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unversity of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.