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Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy

NCT05135351 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135351 on ClinicalTrials.gov