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

NCT ID: NCT02763033

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2026-04-30

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).

Conditions

Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Bob's Red Mill®

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.

Group Type: EXPERIMENTAL

Bob's Red Mill®

Intervention Type: DRUG

Standard bone marrow transplant (BMT) diet + potato-based starch

Starch Placebo

Intervention Type: OTHER

Standard bone marrow transplant (BMT) diet + corn-based starch

Starch Placebo

Patients will receive an iso-caloric, non-resistant starch placebo.

Group Type: PLACEBO_COMPARATOR

Starch Placebo

Intervention Type: OTHER

Standard bone marrow transplant (BMT) diet + corn-based starch

Interventions

Bob's Red Mill®

Standard bone marrow transplant (BMT) diet + potato-based starch

Intervention Type: DRUG

Starch Placebo

Standard bone marrow transplant (BMT) diet + corn-based starch

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary M Riwes, D.O.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary M Riwes, D.O

Role: CONTACT

mmriwes@med.umich.edu

734-936-8785

Facility Contacts

Mary Riwes, DO

Role: primary

mmriwes@med.umich.edu

734-936-8785

References

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.

Reference Type: DERIVED

PMID: 37857710 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37189240 (View on PubMed)

Other Identifiers

HUM00112318

Identifier Type: OTHER

Identifier Source: secondary_id

P01HL149633

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2016.029

Identifier Type: -

Identifier Source: org_study_id