Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

Study Overview
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Brief Summary
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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).

Official Title
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Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Bob's Red Mill®
* Other: Starch Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing matched related full intensity allogeneic HSCT (hematopoietic stem cell transplantation) 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 (human leukocyte antigen) matched related 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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bob's Red Mill®<br>Patients will follow the standard BMT (bone marrow transplant) diet and add potato-starch produced by Bob's Red Mill® beginning on day -7 and continuing through day +100.Patients will consume 20 g of Bob's Red Mill®, Potato-based dietary starch, orally twice daily. Initially, subjects will take 20g daily for first three days prior to increasing dose to 20 g BID. | Drug: Bob's Red Mill®<br>* Standard bone marrow transplant (BMT) diet + potato-based starch<br>Other: Starch Placebo<br>* Standard bone marrow transplant (BMT) diet + corn-based starch<br>|
| Placebo Comparator: Starch Placebo<br>Patients will receive an iso-caloric, non-resistant starch placebo. | Other: Starch Placebo<br>* Standard bone marrow transplant (BMT) diet + corn-based starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade II-IV GVHD | 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. | Day 100 |