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

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02763033
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
83.2
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Bob's Red Mill®
  • Other: Starch Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
Actual Study Start Date :
Apr 26, 2017
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Cancer Center Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Pavan Reddy, M.D., University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT02763033
Other Study ID Numbers:
  • UMCC 2016.029
  • HUM00112318
First Posted:
May 5, 2016
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 17, 2021