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Potato starch may protect stem cell transplant patients from deadly immune attack

NCT ID NCT02763033

Disease control Sponsor: University of Michigan Rogel Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a potato-based starch supplement could reduce the risk of graft-versus-host disease (GVHD) in 107 people receiving stem cell transplants. GVHD occurs when donor immune cells attack the patient's body. The supplement is designed to increase butyrate, a gut-friendly compound, to calm the immune system. Participants took the starch daily from before transplant until day 100, and researchers tracked how many developed moderate to severe GVHD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
potato-based resistant starch (dietary supplement)
What this could lead to
If it works, this simple dietary supplement could help prevent a serious complication of stem cell transplants, making the procedure safer for many patients.
What could go wrong
This is a small, early-phase trial, so results may not be conclusive. The supplement might not reduce GVHD enough to change standard care, and some people may have digestive side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

Apr 2017

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic stem cell transplantation

Contacts and locations

Locations

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109, United States

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