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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00112318 | Other Identifier | The University of Michigan | |
| P01HL149633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bob's Red MillĀ® | Experimental | Patients will follow the standard BMT (bone marrow transplant) diet and add potato-starch produced by Bob's Red MillĀ® beginning on day -7 and continuing through day +100.Patients will consume 20 g of Bob's Red MillĀ®, 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. |
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| Starch Placebo | Placebo Comparator | Patients will receive an iso-caloric, non-resistant starch placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bob's Red MillĀ® | Drug | Standard bone marrow transplant (BMT) diet + potato-based starch |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary M Riwes, D.O. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37857710 | Derived | Riwes MM, Golob JL, Magenau J, Shan M, Dick G, Braun T, Schmidt TM, Pawarode A, Anand S, Ghosh M, Maciejewski J, King D, Choi S, Yanik G, Geer M, Hillman E, Lyssiotis CA, Tewari M, Reddy P. Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. Nat Med. 2023 Nov;29(11):2805-2813. doi: 10.1038/s41591-023-02587-y. Epub 2023 Oct 19. | |
| 37189240 | Derived | Lakshmanan AP, Deola S, Terranegra A. The Promise of Precision Nutrition for Modulation of the Gut Microbiota as a Novel Therapeutic Approach to Acute Graft-versus-host Disease. Transplantation. 2023 Dec 1;107(12):2497-2509. doi: 10.1097/TP.0000000000004629. Epub 2023 May 16. |
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| Starch Placebo |
| Other |
Standard bone marrow transplant (BMT) diet + corn-based starch |
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