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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100

Awards & highlights

Study Summary

This trial is testing whether a potato-based dietary supplement can help reduce acute GVHD in stem cell transplant patients.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,156 Total Patients Enrolled

Pavan Reddy, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center

Mary M Riwes, D.O.Principal InvestigatorUniversity of Michigan Rogel Cancer Center

Media Library

Bob's Red Mill® (Resistant Starch) Clinical Trial Eligibility Overview. Trial Name: NCT02763033 — Phase 2

Bob's Red Mill® (Resistant Starch) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02763033 — Phase 2

Bone Marrow Transplant Research Study Groups: Bob's Red Mill®, Starch Placebo

Bone Marrow Transplant Clinical Trial 2023: Bob's Red Mill® Highlights & Side Effects. Trial Name: NCT02763033 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for participation in this research?

"Affirmative. Clinicaltrials.gov provides evidence that this medical study has been actively recruiting since April 26th 2017, with the most recent edits made on December 16th 2021. Participation of 70 subjects is sought in a single location."

Answered by AI

What risks might be associated with consuming Bob's Red Mill® products?

"Our team at Power have evaluated Bob's Red Mill® and granted it a rating of 2. This is because the clinical trial for this particular product has only reached Phase 2, meaning that there are some safety metrics available but no efficacy data yet."

Answered by AI

Is there still potential for enrollment in this study?

"According to clinicaltrials.gov, this medical research is currently recruiting participants; the trial was initially announced on April 26th 2017 and received its most recent update in December 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

2017. "Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02763033.

All > Gvhd > Microbiome