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A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization

NCT07792915 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Clostridium Infections
  • Methicillin-resistant Staphylococcus Aureus (MRSA)
  • Vancomycin-Resistant Enterococci
  • Carbapenem-Resistant Enterobacteriaceae
  • Asymptomatic Infections

Interventions

DRUG

Resistant Potato Starch

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.

DRUG

Maltodextrin

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Nasia Safdar, MD PhD · William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-12-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792915 on ClinicalTrials.gov