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
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-myeloma
Started Jun 2022
Longer than P75 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedStudy Start
First participant enrolled
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 20, 2026
November 1, 2025
6.1 years
November 18, 2021
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
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
35 Days
Secondary Outcomes (4)
Hospital Duration
25 days
Rate of Neutropenic Fever
25 Days
Rate of broad-spectrum antibiotic exposure
25 Days
Rate of gastrointestinal symptoms
35 Days
Study Arms (2)
Treatment
EXPERIMENTALresistant starch
Placebo
PLACEBO COMPARATORmaltodextrin
Interventions
A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R D'Angelo, MD
University of Nebraska
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2021
First Posted
November 26, 2021
Study Start
June 7, 2022
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
April 20, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share