RECRUITING

Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Pilot, Randomized, Double-blind, Placebo-controlled Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation in Multiple Myeloma and Lymphoma: The PRIMAL Trial

Quick Facts

Study Start:2022-04-13
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05135351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing to provide informed consent
  2. 2. Willing to comply with all study procedures and be available for the duration of the study
  3. 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. 4. Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
  5. 5. Adult Individuals (male or female) at least 19 years of age
  6. 6. Meeting indications and recommended for first autologous stem cell transplantation by investigator
  1. 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. 2. Previous intolerance to fiber supplementation
  3. 3. Allergy or intolerance to potato starch or maltodextrin
  4. 4. Subject unwilling to comply with stool sample collection
  5. 5. Not suitable for study participation due to other reasons at the discretion of the investigators

Contacts and Locations

Study Contact

Jayson Henrickson, MS
CONTACT
402-559-3810
jayson.henrickson@unmc.edu
Taylor A Johnson, BS, MA
CONTACT
402-559-0963
taylora.johnson@unmc.edu

Principal Investigator

Christopher R D'Angelo, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Christopher R D'Angelo, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-13
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-04-13
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Lymphoma