Using a dietary supplement to reduce complications in stem cell transplant patients

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

This study is testing whether a potato-based dietary supplement can help stem cell transplant patients have fewer complications and feel better after their treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: University of Michigan Rogel Cancer Center (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT02763033 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and early effectiveness of a dietary supplement containing potato-based resistant starch in patients undergoing allogeneic stem cell transplantation. The intervention starts before the conditioning phase and continues until day 100 post-transplant. Researchers hypothesize that this supplement can increase butyrate levels in the intestine, potentially reducing the incidence of acute graft-versus-host disease (GVHD). The study aims to assess the feasibility of this dietary manipulation in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older, or children aged 10 and older weighing at least 50 kg, who are undergoing matched allogeneic stem cell transplantation.

Not a fit: Patients with inflammatory bowel disease, a history of gastric bypass surgery, or active Clostridium difficile infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rates of acute GVHD in stem cell transplant patients.

How similar studies have performed: While dietary manipulation of the microbiome is a novel approach, similar studies have shown promise in other contexts, though this specific intervention is less tested.

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.

Where this trial is running

Ann Arbor, Michigan

• University of Michigan Cancer Center — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Mary M Riwes, D.O. — University of Michigan Rogel Cancer Center
• Study coordinator: Mary M Riwes, D.O

Conditions Hematopoietic Stem Cell Transplantation