What side effects are associated with this type of intervention?

Common treatments for bone marrow transplant, particularly those aimed at reducing acute graft-versus-host disease (GVHD), include myeloablative and nonmyeloablative conditioning regimens. Myeloablative regimens are associated with significant toxicities, including hematologic, gastrointestinal, hepatic, hemorrhagic, infectious, metabolic, and pulmonary complications, with treatment-related mortality rates of 30 to 50 percent. Nonmyeloablative regimens, while less toxic, still carry risks such as infections and organ toxicity. The use of dietary interventions like potato-based resistant starch to increase intestinal butyrate levels is being studied to mitigate these side effects, particularly to reduce the incidence and severity of acute GVHD.

What prior FDA approvals exist?

FDA-approved treatments for bone marrow transplant patients, particularly for reducing acute GVHD, include drugs like romiplostim and eltrombopag. These thrombopoietin receptor agonists have been studied for their potential to enhance platelet recovery and reduce bleeding risks post-transplant. While not directly increasing intestinal butyrate levels, these treatments aim to manage hematologic complications and improve patient outcomes post-transplant.

What other types of research exist?

Promising alternatives to potato-based resistant starch for increasing intestinal butyrate levels and reducing acute GVHD in bone marrow transplant patients include oral beclomethasone dipropionate (BDP), which has shown efficacy in preventing acute gastrointestinal GVHD. Additionally, dietary interventions such as the Crohn's Disease Exclusion Diet (CDED) combined with partial enteral nutrition, and specific carbohydrate diets may also be considered for their potential anti-inflammatory effects and ability to modulate gut microbiota.

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Resistant Starch

Potato-Based Supplement for Bone Marrow Transplant Patients

Phase 2

Recruiting

Led By Pavan Reddy, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky >70%

Subjects undergoing matched related full intensity allogeneic HSCT (hematopoietic stem cell transplantation)

Must not have

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 with inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the dietary intervention may include digestive discomfort or reactions due to changes in gut microbiota from increased butyrate production; however, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am getting a stem cell transplant from a closely related donor.

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I have a family member who is an HLA match for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active Clostridium difficile infection confirmed by a stool test.

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I have inflammatory bowel disease.

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I have had gastric bypass surgery in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of grade II-IV GVHD

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bone marrow transplant (BMT) patients include dietary interventions like potato-based resistant starch, which increases intestinal butyrate levels to reduce acute graft-versus-host disease (GVHD). Butyrate has anti-inflammatory properties and supports gut barrier function, helping to mitigate GVHD. Additionally, immunosuppressive drugs are used to prevent GVHD, and growth factors are administered to promote hematopoietic recovery. These treatments are crucial for reducing complications and enhancing recovery in BMT patients.

Evaluation of oral beclomethasone dipropionate for prevention of acute graft-versus-host disease.