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
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: D'Angelo, Christopher
Contact Information:
Emily Gale
emily.gale@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05135351?term=NCT05135351&rank=1
Summary
Primary
1) To understand the feasibility of the intervention in the proposed study population
2) To explore the impact of a prebiotic intervention on gut microbiome diversity post-transplant.
Secondary
1) To evaluate the duration of hospitalization according to intervention assignment
2) To evaluate the impact of dose intensity of resistant starch on gut microbiota composition
3) To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment.
4) To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment
5) To determine the rate of gastrointestinal symptoms according to intervention assignment
Correlative/exploratory
1) To determine the feasibility of using the ASA24 dietary survey in subjects undergoing stem cell transplantation
2) To investigate the dietary intake in subjects undergoing stem cell transplantation
3) To investigate the change to gut microbiota according to pre-transplant dietary intake
4) To investigate the impact of polyphenol intake on gut microbiota composition and transplant toxicity
5) To evaluate markers of gut permeability in the peripheral blood
6) To assess changes to gut microbiome sub-populations following the prebiotic intervention, namely the effect of prebiotics on butyrate-producing species including bifidobacteria, lactobacilli species, Eubacterium species, and clostridial species.
CAR T-Cell Cohort Objectives
Primary
1) To determine the difference in composite quantitative abundance of Faecalibacterium prausnitzii, Ruminococcus species, and Akkermansia Mucinophila
Secondary
1) To explore the impact of a prebiotic intervention on gut microbiome diversity post-CAR T-cell infusion
2) To determine the rate of broad-spectrum antibiotic exposure during CAR T-cell therapy according to intervention assignment
3) To determine the rate of gastrointestinal symptoms according to intervention assignment
4) To evaluate the feasibility of the prebiotic regimen
Correlative/exploratory
1) To evaluate markers of gut permeability in the peripheral blood
2) To evaluate impact of prebiotic intervention on circulating t-lymphocyte populations
3) To evaluate the relationship between the gut microbiome and circulating T-cell populations