Potato-Based Supplement for Bone Marrow Transplant Patients

Overseen By Mary M Riwes, D.O

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a potato-based supplement to determine if it can reduce acute GVHD, a common complication where transplanted cells attack the body, in patients undergoing a type of bone marrow transplant. Participants will take the supplement, known as Bob's Red Mill®, before and after their transplant. Researchers aim to assess its safety and effectiveness. Individuals with a matched donor who are about to undergo a bone marrow transplant may be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

Research has shown that resistant potato starch, such as that in Bob's Red Mill®, is generally safe for use. In past studies, adults who consumed 20 grams daily did not experience serious side effects. For example, one study with ten adults found the starch well-tolerated, with no major problems reported.

The potato starch used in these studies is available in stores and has been tested in various settings, supporting its safety. Since this clinical trial is in the middle stages, the treatment has already been deemed safe enough to progress beyond initial tests. This suggests it is generally well-tolerated, but researchers will continue monitoring for any new side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard bone marrow transplant care, which typically includes a strict diet to manage complications, this new approach incorporates Bob's Red Mill® potato-based dietary starch. Researchers are excited about this treatment because it introduces a unique, natural ingredient that could potentially enhance gut health and improve recovery outcomes for patients. The potato starch is resistant, meaning it isn't easily digested in the stomach and small intestine, potentially fostering beneficial gut bacteria when it reaches the colon. This could offer a novel support mechanism for patients, complementing existing care strategies in a simple, dietary form.

What evidence suggests that this potato-based supplement is effective for reducing acute GVHD in bone marrow transplant patients?

Research has shown that resistant potato starch, like the kind found in Bob's Red Mill®, might improve gut health by increasing butyrate levels in the intestine. Butyrate is a beneficial substance that can help reduce inflammation. In this trial, some participants will receive Bob's Red Mill® resistant potato starch, while others will receive a starch placebo. Studies suggest that increasing butyrate levels might lower the risk of acute GVHD (Graft-Versus-Host Disease), a common issue after a bone marrow transplant. Early evidence indicates that fiber supplements, such as resistant potato starch, may improve outcomes for patients undergoing these transplants. This type of starch may help maintain a healthier gut during the transplant process. ^{1 4 5 6 7}

Who Is on the Research Team?

Mary Riwes, DO

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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 can swallow pills.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02763033

Study Details | NCT02763033 | Dietary Manipulation of the ... Experimental : Bob's Red Mill®. Patients will follow the standard BMT (bone marrow transplant) diet and add potato-starch produced by Bob's Red Mill® beginning ...

2. withpower.com withpower.com/trial/phase-3-3-2017-fc399

Potato-Based Supplement for Bone Marrow Transplant ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10667101/

Feasibility of a dietary intervention to modify gut microbial ... Ten adults received resistant potato starch (RPS) daily from day −7 to day 100. The primary objective was to test the feasibility of RPS and its ...

4. michiganmedicine.org michiganmedicine.org/health-lab/potato-starch-supplements-could-be-solution-bone-marrow-transplant-complications

Potato starch supplements could be solution to bone marrow ... This phase II clinical trial will help researchers learn whether or not taking potato starch is an effective intervention for preventing GVHD.

5. mdpi.com mdpi.com/2072-6643/17/18/2973

A Systematic Review Evaluating the Impact of Fibre ... Conclusions: Fibre supplementation represents a promising adjunctive strategy to improve clinical outcomes in adults with HMs undergoing HCT, by improving ...

6. nature.com nature.com/articles/s41591-023-02587-y

Feasibility of a dietary intervention to modify gut microbial ... Ten adults received resistant potato starch (RPS) daily from day −7 to day 100. The primary objective was to test the feasibility of RPS and its ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06784336

NCT06784336 | Phase II Study of Resistant Potato Starch ... The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron ...