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

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · May 3, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a dietary supplement made from potato-based resistant starch to see if it can help reduce a condition called acute Graft-Versus-Host Disease (GVHD) in patients undergoing a type of cancer treatment known as allogeneic stem cell transplantation (SCT). GVHD can happen when the new cells from a donor attack the recipient's body. The researchers believe that this supplement may increase beneficial substances in the gut, which could lower the chances of developing GVHD. The study will begin before the transplant process and continue for about 100 days afterward.

To participate in this trial, patients need to be 10 years or older, weigh at least 50 kg (about 110 pounds), and be undergoing a specific type of stem cell transplant from a matched related donor. They should also be able to swallow pills and understand the study details. However, patients with certain conditions, such as inflammatory bowel disease or those who have had gastric bypass surgery, cannot participate. If eligible, participants will receive the dietary supplement and be monitored for safety and effectiveness throughout the trial, contributing to important research that could improve outcomes for future patients.

Gender

ALL

Eligibility criteria

• 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.