University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT02763033
Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditioning phase and continue through day 100. Investigators hypothesize that short term administration of a resistant starch is capable of increasing levels of butyrate within the intestine that will reduce rates of acute GVHD (Graft-Versus-Host Disease).
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Notify Me10 year and older
All sexes
Interventional
Phase 2
Ann Arbor, Michigan, 48109, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard bone marrow transplant (BMT) diet + potato-based starch
Standard bone marrow transplant (BMT) diet + corn-based starch
Time frame: Day 100
The incidence of grade II, III and IV GVHD (Graft Versus Host Disease) as documented on day 100
Grade II: Rash 25-50% of Body Surface Area (BSA), Bilirubin 3.1-6mg/dL, adult stool output 1000-1500mL/day or child 20-30mL/kg/day.
Grade III: Rash greater than 50% BSA, bilirubin 6.1-15mg/dL, adult stool output greater than 1500mL/day or child stool output greater than 30mL/kg/day
Grade IV: generalized erythroderma plus bullous formation and desquamation greater than 5% BSA, bilirubin greater than 15mg/dL, severe abdominal pain with or without ileus, or grossly bloody stool.
University of Michigan Rogel Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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