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RECRUITING
NCT05135351
NA

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

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-04-13

Completion Date

2028-07

Last Updated

2025-11-19

Healthy Volunteers

No

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

Locations (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States