Potato-Based Supplement for Bone Marrow Transplant Patients
Recruiting in Palo Alto (17 mi)
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.
12345How 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.
678910Eligibility 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.
+4 more
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
+2 more
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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Michigan Cancer CenterAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer CenterLead Sponsor
References
Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]Evaluation of the impact of dietary intervention on gastrointestinal microbiota and metabolites after allogeneic hematopoietic stem cell transplantation (HCT) is lacking. We conducted a feasibility study as the first of a two-phase trial. 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 effect on intestinal microbiome and metabolites, including the short-chain fatty acid butyrate. Feasibility met the preset goal of 60% or more, adhering to 70% or more doses; fecal butyrate levels were significantly higher when participants were on RPS than when they were not (P
Effect of feeding raw potato starch on the composition dynamics of the piglet intestinal microbiome. [2022]Raw potato starch (RPS) is resistant to digestion, escapes absorption, and is metabolized by intestinal microflora in the large intestine and acts as their energy source. In this study, we compared the effect of different concentrations of RPS on the intestinal bacterial community of weaned piglets.
Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]Resistant starch (RS) is part of potato starch that is not digested in the gastrointestinal tract. RS4 is a chemically modified starch (for example by oxidation and esterification) and physically (by heating).
Responses in colonic microbial community and gene expression of pigs to a long-term high resistant starch diet. [2020]Intake of raw potato starch (RPS) has been associated with various intestinal health benefits, but knowledge of its mechanism in a long-term is limited. The aim of this study was to investigate the effects of long-term intake of RPS on microbial composition, genes expression profiles in the colon of pigs. Thirty-six Duroc × Landrace × Large White growing barrows were randomly allocated to corn starch (CS) and RPS groups with a randomized block design. Each group consisted of six replicates (pens), with three pigs per pen. Pigs in the CS group were offered a corn/soybean-based diet, while pigs in the RPS group were put on a diet in which 230 g/kg (growing period) or 280 g/kg (finishing period) purified CS was replaced with purified RPS during a 100-day trial. Real-time PCR assay showed that RPS significantly decreased the number of total bacteria in the colonic digesta. MiSeq sequencing of the V3-V4 region of the 16S rRNA genes showed that RPS significantly decreased the relative abundance of Clostridium, Treponema, Oscillospira, Phascolarctobacterium, RC9 gut group, and S24-7-related operational taxonomic units (OTUs), and increased the relative abundance of Turicibacter, Blautia, Ruminococcus, Coprococcus, Marvinbryantia, and Ruminococcus bromii-related OTUs in colonic digesta and mucosa. Analysis of the colonic transcriptome profiles revealed that the RPS diet changed the colonic expression profile of the host genes mainly involved in immune response pathways. RPS significantly increased proinflammartory cytokine IL-1β gene expression and suppressed genes involved in lysosome. Our findings suggest that long-term intake of high resistant starch (RS) diet may result in both positive and negative roles in gut health.
Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]The effects of resistant starch (RS) in dry potato powders prepared by various processes on intestinal fermentation in rats were assessed. Rats were fed raw potato powder (RP), blanched potato powder (BP), steamed potato powder (SP), or drum-dried potato powder (DP) for 4 weeks. The cecal RS content was significantly higher in the RP group than in the control diet (CN) group and other dry potato powder groups. Cecum pH was significantly lower in the RP group compared to the CN group, and was also significantly lower than that in the SP, BP, and DP groups. Lactic acid bacteria levels in the RP group were significantly higher than those in the CN group, and levels in the SP group also increased relative to the control group. Lactobacillus levels in the RP group were higher than in the CN and other dry potato powder groups. Cecal short-chain fatty acid (SCFA) concentrations in the RP group followed by the SP group exhibited significantly higher levels relative to the control levels. Dry potato powders containing RS produced during the cooking process may represent a useful food material that increases intestinal concentrations of SCFA and enhances the growth of certain lactic acid bacteria.
Food and nutrition services in bone marrow transplant centers. [2004]Nutrition care for bone marrow transplant recipients is recognized as vital for a successful transplant, yet little research has been done to determine the most effective foodservice methods. Many decisions regarding methods for the oral feeding of bone marrow transplant patients are based on tradition and/or individual judgments. This study surveyed marrow transplant centers to identify existing food and nutrition services that could be used as a basis for developing a foodservice protocol. A survey instrument was developed and sent to all chief dietitians (no. = 35) affiliated with transplantation centers in the United States. Four of the 30 respondents reported changing from the traditional sterile diet to either a low-bacteria or a modified house diet. Problems of limited availability of single-serve sterile foods, lack of standardization of recipes, and low patient acceptance of autoclaved sterile foods were reported as reasons for the move toward less stringent dietary procedures. The responses clearly indicate the need for additional research before a foodservice model can be established.
Food intake patterns and foodservice requirements on a marrow transplant unit. [2016]Marrow transplantation (MT) is used for treatment of lymphomas and hematological malignancies. The preparative regimens (including high-dose chemoradiotherapy), as well as infections, medications, and graft-versus-host disease, result in nutritional complications. In order to determine foodservice needs, hospital personnel tabulated the foods requested and the daily number of meals ordered by 205 MT patients the final 14 days before their initial post-transplant hospital discharge. Oral and total (oral plus parenteral) caloric intakes were calculated from weighted food intake records using a computerized nutrient database. Per patient meal orders increased from 2.6 +/- 2.2 (SD) to 5.3 +/- 2.0 per day, and the mean number of items per day increased from 4.9 +/- 4.9 to 12.4 +/- 4.9, 14 days vs. 1 day prior to discharge. Beverages were the most frequently requested item, followed by bread products and cooked fruits and vegetables. Patients consumed approximately 60% of total calories from oral intake 1 day prior to discharge. The foodservice must be designed to provide a variety of foods served at frequent intervals to meet the needs of MT patients and thereby reduce dependence on parenteral nutrition.
Nutrition issues in hematopoietic stem cell transplantation: state of the art. [2017]There have been many changes in hematopoietic stem cell transplantation (HSCT) that affect the patient's nutrition support. In the early 1970s, allogeneic transplants were the most common types of HSCTs; today, autologous transplants are the most common. Bone marrow, peripheral blood, and umbilical cord blood all now serve as sources of stem cells. Conditioning therapies include myeloablative, reduced-intensity myeloablative, and nonmyeloablative regimens. New medications are being developed and used to minimize the toxicities of the conditioning therapy and to minimize infectious complications. Supportive therapies for renal and liver complications have changed. In the past, HSCT patients received parenteral nutrition (PN) throughout their hospitalization and sometimes as home therapy. Because of medical complications and cost issues associated with PN, many centers are now working to use less PN and increase use of enteral nutrition. The immunosuppressed diet has changed from a sterile diet prepared under laminar-flow hoods to a more liberal diet that avoids high-risk foods and emphasizes safety in food handling practices. This article will review these changes in HSCT and the impact of these changes on the nutrition support of the patient.
Nutrition support for bone marrow transplant patients. [2022]This is an update of the original Cochrane review published in Issue 2, 2002. Bone marrow transplantation involves administration of toxic chemotherapy and infusion of marrow cells. After treatment, patients can develop poor appetite, mucositis and gastrointestinal failure, leading to malnutrition. To prevent this, parenteral nutrition (PN) support is often first choice but is associated with increased risk of infection. Enteral nutrition (EN) is an alternative, as is addition of substrates.
[Prospective comparative study of different amino acid and lipid solutions in parenteral nutrition of patients undergoing bone marrow transplantation]. [2013]The patient who will undergo a bone marrow transplant (BMT) has a high protein catabolism in the time period after the infusion of the marrow, and therefore there is a need for an adequate nutritional support. The objective of our study is to analyze the behavior of nutritional assessment parameters, the lipid metabolism, the number of days of mucositis, the number of infections, the number of days to recovery, and the number of hospitalization days when using different parenteral nutrition solutions: 22.5% and 45% branched chain amino acid solutions, and lipid solutions with long chain triglycerides (LCT), vs. medium chain triglycerides (MCT).