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

March 19, 2026 updated by: University of Michigan Rogel Cancer Center
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Bob's Red Mill®
Standard bone marrow transplant (BMT) diet + potato-based starch
Other: Starch Placebo
Standard bone marrow transplant (BMT) diet + corn-based starch
Placebo Comparator: Starch Placebo
Patients will receive an iso-caloric, non-resistant starch placebo.
Other: Starch Placebo
Standard bone marrow transplant (BMT) diet + corn-based starch

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mary M Riwes, D.O., University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

December 29, 2025

Study Completion (Actual)

December 29, 2025

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimated)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • UMCC 2016.029
  • HUM00112318 (Other Identifier: The University of Michigan)
  • P01HL149633 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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