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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT05135351
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Resistant Starch — DIETARY_SUPPLEMENT
    A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
  • Maltodextrin — DIETARY_SUPPLEMENT
    A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed

Study Details

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.

Key Dates

Start date
Jun 7, 2022
Status verified
Nov 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment
    resistant starch
  • Placebo Comparator: Placebo
    maltodextrin

Primary Outcome Measure

Percentage of subjects who adhere to >70% of scheduled doses of the intervention [ Time Frame: 35 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Nebraska Medical CenterOmahaNebraska68198
Christopher R D'Angelo, MD
402-559-8013

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