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_SUPPLEMENTA prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
- Maltodextrin — DIETARY_SUPPLEMENTA 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: Treatmentresistant starch
- Placebo Comparator: Placebomaltodextrin
Primary Outcome Measure
Percentage of subjects who adhere to >70% of scheduled doses of the intervention [ Time Frame: 35 Days ]
Central Contacts
- Jayson Henrickson, MS402-559-3810
- Taylor A Johnson, BS, MA402-559-0963
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Omaha | Nebraska | 68198 |
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