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

Phase 2

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Other: Starch Placebo; Drug: Bob's Red Mill®

• Registration Number: NCT02763033
• Lead Sponsor: University of Michigan Rogel Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2017-04-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starch Placebo	Starch Placebo	Patients will receive an iso-caloric, non-resistant starch placebo.
Bob's Red Mill®	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.
Bob's Red Mill®	Starch Placebo	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.

Primary Outcome Measures

Name	Time	Method
Incidence of grade II-IV GVHD	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.

Trial Locations

Locations (1)

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States