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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hematopoietic Stem Cell Transplantation

In brief

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).

Key facts

Study ID

NCT02763033

Run by

University of Michigan Rogel Cancer Center

People needed

107

Starts

2017-04-26

Expected to finish

2025-12-29

Last updated by the study team

2026-03-24

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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