Potato-Based Supplement for Bone Marrow Transplant Patients

Overseen by Mary Riwes, DO

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Michigan Rogel Cancer Center

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

Prior Safety Data

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

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 at least 18 years old for the initial phase, or over 10 and weigh more than 50 kg for the next phase.

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

Trial 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® (Resistant Starch)
• Starch Placebo (Other)

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

Group I: Bob's Red Mill® Experimental Treatment 2 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 Placebo Placebo Group 1 Intervention

Patients will receive an iso-caloric, non-resistant starch placebo.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Marschall S. Runge

University of Michigan Rogel Cancer Center

Chief Executive Officer since 2015

MD, PhD

Eric R. Fearon

University of Michigan Rogel Cancer Center

Chief Medical Officer since 2016

MD, PhD

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

Long-term intake of raw potato starch (RPS) in pigs led to significant changes in gut microbial composition, decreasing harmful bacteria like Clostridium and increasing beneficial bacteria such as Ruminococcus, which may contribute to improved intestinal health.

The RPS diet also altered gene expression in the colon, increasing pro-inflammatory cytokine IL-1β while suppressing lysosomal genes, indicating that while RPS may have benefits, it could also have negative effects on gut health through immune response modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. Sun, Y., Zhou, L., Fang, L., et al.[2020]

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 survey of 30 bone marrow transplant centers revealed that only 4 had shifted from traditional sterile diets to less restrictive options like low-bacteria or modified house diets, indicating a trend towards more patient-friendly foodservice methods.

Challenges such as limited availability of sterile foods and low patient acceptance of autoclaved options highlight the need for further research to develop standardized foodservice protocols for transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food and nutrition services in bone marrow transplant centers. Dezenhall, A., Curry-Bartley, K., Blackburn, SA., et al.[2004]

Marrow transplantation patients showed a significant increase in meal orders from an average of 2.6 to 5.3 meals per day in the final 14 days before discharge, indicating a heightened need for nutritional support during recovery.

Patients consumed about 60% of their total calories from oral intake just one day before discharge, highlighting the importance of providing a diverse and frequent foodservice to reduce reliance on parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food intake patterns and foodservice requirements on a marrow transplant unit. Gauvreau-Stern, JM., Cheney, CL., Aker, SN., et al.[2016]

Hematopoietic stem cell transplantation (HSCT) has evolved from primarily allogeneic transplants in the 1970s to predominantly autologous transplants today, which impacts nutritional support strategies for patients.

There is a shift from reliance on parenteral nutrition (PN) to increased use of enteral nutrition, alongside a more liberalized immunosuppressed diet that focuses on food safety, reflecting advancements in supportive therapies and a better understanding of patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition issues in hematopoietic stem cell transplantation: state of the art. Lipkin, AC., Lenssen, P., Dickson, BJ.[2017]

Parenteral nutrition (PN) with added glutamine can reduce the incidence of positive blood cultures in bone marrow transplant patients compared to standard PN, suggesting a potential benefit in infection control.

However, the update indicates that PN with glutamine may not significantly shorten hospital stays, and intravenous fluids or oral diets should be preferred when possible, reserving PN for cases of severe gastrointestinal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition support for bone marrow transplant patients. Murray, SM., Pindoria, S.[2022]

In a study of 62 patients undergoing bone marrow transplants, those receiving parenteral nutrition with 45% branched chain amino acids showed quicker recovery of bone marrow function compared to those receiving lower concentrations, indicating improved metabolic support during recovery.

Using medium chain triglycerides (MCT) in parenteral nutrition resulted in less disruption to lipid metabolism compared to long chain triglycerides (LCT), suggesting that MCT/LCT solutions may be beneficial for managing lipid levels post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospective comparative study of different amino acid and lipid solutions in parenteral nutrition of patients undergoing bone marrow transplantation]. Jiménez Jiménez, FJ., Ortiz Leyba, C., García Garmendia, JL., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of feeding raw potato starch on the composition dynamics of the piglet intestinal microbiome. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Food and nutrition services in bone marrow transplant centers. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Food intake patterns and foodservice requirements on a marrow transplant unit. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Nutrition issues in hematopoietic stem cell transplantation: state of the art. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Nutrition support for bone marrow transplant patients. [2022]

10. Spain pubmed.ncbi.nlm.nih.gov

[Prospective comparative study of different amino acid and lipid solutions in parenteral nutrition of patients undergoing bone marrow transplantation]. [2013]