Hematopoietic Stem Cell Transplantation
Conditions
Brief summary
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).
Interventions
DRUGBob's Red Mill®
Standard bone marrow transplant (BMT) diet + potato-based starch
OTHERStarch Placebo
Standard bone marrow transplant (BMT) diet + corn-based starch
Sponsors
University of Michigan Rogel Cancer Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing matched related and matched unrelated full intensity allogeneic HSCT. * Age ≥ 18 years for the feasibility phase. Age ≥10 years old AND ≥50 kg for the phase II portion. * Karnofsky \>70%, (Karnofsky Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 100 where 100 is "perfect" health and 0 is death.) * Subjects must be able to swallow capsules/tablets * Ability to understand and the willingness to sign a written informed consent * Willingness to consent / co-enroll on BMT long term follow up study or HUM00043287 (UMCC2001-0234) * Availability of an HLA matched related or matched unrelated donor
Exclusion criteria
* Patients with inflammatory bowel disease. * Patients with a history of gastric bypass surgery. * Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via EIA (enzyme immunoassay) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon. * Patients actively enrolled on any other GVHD prevention trial. * Any physical or psychological condition that, in the opinion of the investigator, would post unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade II-IV GVHD | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary M Riwes, D.O.
University of Michigan Rogel Cancer Center
Outcome results
None listed