Resistant Potato Starch for Gut MDRO Decolonization

(MDRO-Fiber Trial)

NS
JA
Overseen ByJulie A Keating, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NS

Nasia Safdar, MD PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

This trial is for Veterans who have carried or had infections with hard-to-treat bacteria in their gut, even if they don't currently have symptoms. Participants should not have conditions that would prevent them from safely taking dietary fiber supplements.

Inclusion Criteria

Presence of C. difficile, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), and/or Multi-drug resistant Enterobacteriaceae (MDRE) in the gut as determined by a stool test
I am able to walk and I am not currently hospitalized.

Exclusion Criteria

Already on a decolonization protocol
Allergy to any ingredient or source material in intervention or placebo product
Pregnancy or breastfeeding
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What Are the Treatments Tested in This Trial?

Interventions

  • Resistant Potato Starch

Trial Overview

The study compares resistant potato starch (a type of dietary fiber) to maltodextrin (a placebo) to see if the fiber can help reduce harmful bacteria in the gut. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PrebioticExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+