Potato Resistant Starch + Iron Chelation for Stem Cell Transplant

Overseen By Mary Riwes

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Deferasirox

Disqualifiers: Inflammatory bowel disease, Gastric bypass, Clostridium difficile, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and early effectiveness of a potato-based resistant starch combined with iron chelation therapy (a treatment to remove excess iron) for patients receiving stem cell transplants. It targets those with blood disorders receiving a transplant from a closely matched donor. Participants must be able to swallow pills and have a suitable donor ready. The study seeks to determine if this combination can improve outcomes for patients undergoing these transplants. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving treatment for iron overload with deferasirox, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that potato-resistant starch is generally safe and practical for patients undergoing stem cell transplants. In earlier studies, patients experienced noticeable changes in their gut bacteria, which were expected and not harmful. Overall, no major safety concerns have been found with using this starch.

Iron chelation therapy is a well-known treatment that helps control iron levels in the body. This is especially important for individuals undergoing hematopoietic stem cell transplants, as iron can sometimes accumulate to harmful levels. Studies have demonstrated that iron chelation therapy can lower this risk without major safety issues.

Both treatments in the study—potato-resistant starch and iron chelation—have shown promising safety in past research. They appear to be well-tolerated, with no serious side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for conditions requiring stem cell transplants focus on managing symptoms and complications with medications and supportive care. But the combination of Potato Resistant Starch (RPS) and iron chelation offers a novel approach. RPS is unique because it acts as a prebiotic, potentially enhancing gut health and immune function, which are critical for patients undergoing stem cell transplants. Iron chelation helps reduce excess iron in the body, which can be a problem after transplants. Researchers are excited because this dual-action strategy could improve patient outcomes by supporting both gut health and iron balance, tackling two common issues faced by transplant patients.

What evidence suggests that this trial's treatments could be effective for stem cell transplant?

Research has shown that potato resistant starch (RPS) might help increase good bacteria in the gut, benefiting people receiving stem cell transplants. This starch acts like a prebiotic, feeding the helpful bacteria that can reduce complications such as graft-versus-host disease (GVHD) after a transplant. Iron chelation therapy, also included in this trial, lowers iron levels in the body, which is crucial because excess iron can harm patients undergoing stem cell transplants. Effectively managing iron levels can lead to better long-term health for these patients. Both treatments, provided to participants in this trial, show promise in improving the health and recovery of stem cell transplant recipients. ^{1 3 4 5 6}

Who Is on the Research Team?

Mary Riwes

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with blood disorders who are getting a stem cell transplant from a fully matched donor after intense treatment. They must be able to swallow pills, have good physical function, and understand the study. People can't join if they have certain gut diseases, allergies to iron medicine (deferasirox), are in another GVHD prevention trial, had gastric bypass surgery, active C. difficile infection or need treatment for iron deficiency anemia.

Inclusion Criteria

I am getting a stem cell transplant from a matched donor after intense treatment.

Ability to understand and the willingness to sign a written informed consent

I have a donor who matches me completely and can donate cells.

Exclusion Criteria

Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures

I am being treated for active inflammatory bowel disease.

Known hypersensitivity to deferasirox or any component of Jadenu or Exjade

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Deferasirox intervention begins one week prior to the RPS conditioning phase

1 week

Treatment

Participants receive Resistant Potato Starch and Iron Chelation therapy through day +100 post-transplant

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of GVHD-free and relapse-free survival

up to 1 year post-transplantation

What Are the Treatments Tested in This Trial?

Interventions

• Iron chelation
• Potato Resistant Starch

Trial Overview

The study tests if taking a potato-based resistant starch plus iron chelation therapy with deferasirox helps patients undergoing allogeneic stem cell transplantation (alloHCT). It aims to see how safe this combination is and whether it could improve early outcomes post-transplant.

How Is the Trial Designed?

Group I: Study Treatment Experimental Treatment 2 Interventions

All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 32 Wistar rats, the addition of resistant starch RS4 to high-fat diets significantly reduced total cholesterol levels by about 25% and triglycerides by approximately 47% in those fed with soybean oil, indicating its beneficial effects on lipid metabolism.

Rats consuming diets with RS4 also showed lower liver damage, as indicated by hepatic enzyme activity, and higher levels of HDL-cholesterol compared to control groups, suggesting improved overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. Bronkowska, M., Orzeł, D., Łoźna, K., et al.[2013]

Rats fed diets containing various colored potato flakes (white, red, and purple) showed significant improvements in cecal health, including lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs) compared to those on a control diet, indicating enhanced fermentation and beneficial gut bacteria activity.

The study found that the consumption of purple potato flakes led to increased fecal excretion of total and secondary bile acids, suggesting that these potato flakes may positively influence bile acid metabolism and overall colonic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding potato flakes affects cecal short-chain fatty acids, microflora and fecal bile acids in rats. Han, KH., Hayashi, N., Hashimoto, N., et al.[2018]

Rats fed raw potato powder (RP) showed significantly higher levels of resistant starch and beneficial lactic acid bacteria compared to those on a control diet, indicating that RP may enhance gut health.

The RP group also had lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs), suggesting that raw potato powder can positively influence intestinal fermentation and microbial activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. Kawakami, S., Han, KH., Araki, T., et al.[2018]

A feasibility study involving 10 adults showed that daily intake of resistant potato starch (RPS) from day -7 to day 100 after allogeneic hematopoietic stem cell transplantation significantly increased fecal butyrate levels, indicating a positive impact on gut health (P < 0.0001).

The study also found that RPS led to more stable plasma metabolites in participants compared to historical controls, suggesting potential benefits for metabolic health post-transplant, and a phase 2 trial is planned to further investigate its effects on graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. Riwes, MM., Golob, JL., Magenau, J., et al.[2023]

In a study involving rats, potato starch from Snowden and Kitahime varieties improved cecal fermentation by increasing beneficial short-chain fatty acids and lowering cecal pH compared to a control group.

The consumption of potato starch also enhanced immune function by raising cecal immunoglobulin A levels and reducing harmful compounds like ammonia-nitrogen and indole, suggesting potential health benefits for gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Raw Potato Starch with High Resistant Starch Levels on Cecal Fermentation Properties in Rats. Nagata, R., Innami, N., Pelpolage, S., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2943091/

Iron Overload in Patients Undergoing Hematopoietic Stem ...

Recipients of hematopoietic stem cell transplantation (HSCT) frequently have iron overload resulting from chronic transfusion therapy for anemia.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S266663672301254X

Impact of Iron Overload and Iron Chelation with Deferasirox ...

Iron overload significantly negatively impacts hematopoietic stem cell transplantation (HSCT) outcomes in patients with severe aplastic anemia.

3.

astctjournal.org

astctjournal.org/article/S2666-6367(20)30011-7/pdf

Iron Toxicity and Chelation Therapy in Hematopoietic Stem ...

Finally, effective management of late post-transplant iron toxicity may significantly improve long-term patient outcomes. CLINICAL STUDIES ON IRON CHELATION ...

4.

ashpublications.org

ashpublications.org/blood/article/145/4/372/516079/How-I-manage-iron-overload-in-the-hematopoietic

How I manage iron overload in the hematopoietic cell ...

In this article, I discuss the impact of iron toxicity in relation to the different phases of hematopoietic transplantation, before, during, and after.

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0238793

Outcome of iron reduction therapy in ex-thalassemics

With a median follow up of 80 months (range:37–182), target ferritin level of <300ng/ml was achieved in 59(40%) while a level <500ng/ml was ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666636720300117

Iron Toxicity and Chelation Therapy in Hematopoietic Stem ...

Iron chelation therapy may limit iron toxicity in the bone marrow and promote hematologic improvement and engraftment in HSCT recipients.