RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2017-04-26

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02763033

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.

Ages Eligible for Study:10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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

Study Contact

Mary M Riwes, D.O

CONTACT

734-936-8785

mmriwes@med.umich.edu

Principal Investigator

Mary M Riwes, D.O.

PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

Mary M Riwes, D.O., PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

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 Registration Dates

Study Start Date2017-04-26

Study Completion Date2026-04

Study Record Updates

Study Start Date2017-04-26

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic Stem Cell Transplantation