NCT07792915|Not Yet RecruitingPhase 2DMCFDA Drug
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
MDRO-Fiber
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · VA Office of Research and Development
interventional
120
1 country
1
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Multidrug-resistant organisms (MDROs) cause serious infections that are difficult to treat, leading to increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Many risk factors for MDRO infections are present in the Veteran population (such as older age, underlying medical conditions like diabetes, and stays in long-term healthcare settings). Some people can carry these organisms in their gut. Even without current symptoms, carrying these MDROs also increases risk of future infection. Effective, easy to use, and inexpensive interventions to reduce gut carriage of MDROs are needed to reduce risk of infection. Dietary fiber prebiotics have shown promise in improving the healthy gut microbiome, and the investigators have found that individuals with high fiber in their diets have reduced carriage of MDROs in the gut. The investigators propose a randomized controlled trial to test the effectiveness of a dietary fiber prebiotic intervention (resistant potato starch) in reducing gut MDRO carriage in Veterans with a history of MDRO carriage and/or infection. The investigators will also evaluate the effect on the gut microbiome as well as Veterans' experience with the fiber intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2026
Actual (reported)August 28, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Multidrug resistant organism (MDRO) Decolonization
Changes in prevalence of MDRO carriage with one or more MDRO of interest: C. difficile, Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and/or multi-drug resistant Enterobacteriaceae (MDRE)
3 years
Alpha-1-antitrypsin (AAT) levels
3 years
Gut microbiome composition
3 years
Participants assigned to this arm will consume resistant potato starch prebiotic fiber powder as part of their standard diet for 5 weeks. On days 1-4 they will consume 4 grams (g) of product, on days 5-7 they will consume 7g of product, on days 8-35 they will consume 10g of product.
Participants assigned to this arm will consume placebo (maltodextrin) powder as part of their standard diet for 5 weeks. On days 1-4 they will consume 4 grams (g) of product, on days 5-7 they will consume 7g of product, on days 8-35 they will consume 10g of product.
MSPrebiotic (MSPrebiotic Inc, Carberry, Manitoba, Canada). MSPrebiotic is an unmodified resistant starch derived from potatoes (Solanar tuberosum). It consists of 20% amylose and 80% amylopectin forming granules the stomach and small intestine are unable to digest allowing for absorption in the colon. MSPrebiotic is consumed by mixing 10g into cold or room temperature foods or beverages; it is not to be heated.
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254, United States
Nasia Safdar, MD PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
First Submitted
August 11, 2026
First Posted
August 28, 2026
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma
Changes in gut microbiome metabolites
3 years
Multidrug resistant organism (MDRO) Infections
3 years
Intervention acceptability
3 years
The placebo will be 10 grams of digestible maltodextrin powder daily. Maltodextrin is a is a polysaccharide food additive and is white, tasteless, water-soluble powder making it a comparable placebo for the prebiotic. The placebo will be pharmaceutical grade and available over the counter.
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Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 28, 2026
Record last verified: 2026-08
A BioProject will be created with NCBI and sequencing data will be shared there with a limited, deidentified set of metadata from participants. Additional data can be obtained from the research team with permissions.
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Source: ClinicalTrials.gov.
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