105 Participants Needed

Potato-Based Supplement for Bone Marrow Transplant Patients

PR
MM
Overseen ByMary M Riwes, D.O
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the potato-based supplement safe for humans?

A study with bone marrow transplant patients showed that resistant potato starch was feasible to use, and it increased beneficial gut compounds without reporting any safety issues. However, long-term use in animals showed mixed effects on gut health, suggesting both positive and negative impacts.12345

How is the potato-based supplement treatment different from other treatments for bone marrow transplant patients?

The potato-based supplement, Bob's Red Mill®, is unique because it uses resistant potato starch, which may help improve gut health and nutrition in bone marrow transplant patients, unlike traditional treatments that often rely on parenteral nutrition (feeding through a vein) with higher infection risks.678910

What is the purpose of this trial?

This trial is testing a potato-based resistant starch supplement for patients receiving stem cell transplants. The goal is to see if this supplement can safely and effectively reduce a common complication called acute GVHD by boosting a helpful substance in the gut.

Research Team

MM

Mary Riwes, DO

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for individuals over 18 years old (or over 10 and weighing at least 50 kg in phase II) who are undergoing matched related full intensity allogeneic stem cell transplantation. They must have a good performance status, be able to swallow pills, and sign informed consent. Excluded are those with active Clostridium difficile infection, enrolled in other GVHD prevention trials, or with conditions like inflammatory bowel disease.

Inclusion Criteria

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)
I am able to care for myself but may not be able to do active work.
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Exclusion Criteria

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
I currently have an active Clostridium difficile infection confirmed by a stool test.
Patients actively enrolled on any other GVHD prevention trial
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants begin dietary supplement with potato-based resistant starch prior to conditioning phase

1 week
Daily monitoring

Treatment

Participants receive dietary supplement from day -7 to day +100 to mitigate GVHD

15 weeks
Regular follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bob's Red Mill®
  • Starch Placebo
Trial Overview The study tests if a dietary supplement containing potato-based resistant starch can increase intestinal butyrate levels to reduce acute Graft-Versus-Host Disease rates after allogeneic stem cell transplant. It starts before the conditioning phase and continues until day 100 post-transplant.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bob's Red Mill®Experimental Treatment2 Interventions
Patients will follow the standard BMT (bone marrow transplant) diet and add potato-starch produced by Bob's Red Mill® beginning on day -7 and continuing through day +100.Patients will consume 20 g of Bob's Red Mill®, Potato-based dietary starch, orally twice daily. Initially, subjects will take 20g daily for first three days prior to increasing dose to 20 g BID.
Group II: Starch PlaceboPlacebo Group1 Intervention
Patients will receive an iso-caloric, non-resistant starch placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Findings from Research

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.
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]
Feeding weaned piglets a diet supplemented with 5% raw potato starch (RPS) significantly altered their gut bacterial community, promoting beneficial bacteria like Roseburia and reducing harmful bacteria such as Clostridium, which can enhance gut health.
The addition of 5% RPS also increased the production of short-chain fatty acids (SCFAs), which are important for gut health, suggesting that RPS could be an effective feed additive to help prevent diarrhea in piglets during the weaning process.
Effect of feeding raw potato starch on the composition dynamics of the piglet intestinal microbiome.Yi, SW., Lee, HG., So, KM., et al.[2022]
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.
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]

References

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]
Effect of feeding raw potato starch on the composition dynamics of the piglet intestinal microbiome. [2022]
Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]
Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. [2020]
Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]
Food and nutrition services in bone marrow transplant centers. [2004]
Food intake patterns and foodservice requirements on a marrow transplant unit. [2016]
Nutrition issues in hematopoietic stem cell transplantation: state of the art. [2017]
Nutrition support for bone marrow transplant patients. [2022]
[Prospective comparative study of different amino acid and lipid solutions in parenteral nutrition of patients undergoing bone marrow transplantation]. [2013]
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