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

University of Michigan Rogel Cancer Center

Status and phase

Enrolling

Phase 2

Conditions

Hematopoietic Stem Cell Transplantation

Treatments

Drug: Bob's Red Mill®

Other: Starch Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02763033

UMCC 2016.029

HUM00112318 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

105 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups, including a placebo group

Bob's Red Mill®

Experimental group

Description:

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.

Treatment:

Other: Starch Placebo

Drug: Bob's Red Mill®

Starch Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Starch Placebo