A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization

NCT07792915 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: INFA-002-25FI01RD001117-01-A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clostridioides; methicillin-resistant Staphylococcus aureus; Drug resistance, multiple; Gastrointestinal microbiome; Veterans; Dietary fiber; Prebiotics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Alpha-1-antitrypsin (AAT) levels

  3 years

• Gut microbiome composition

  3 years

• Changes in gut microbiome metabolites

  3 years

Other Outcomes (2)

• Multidrug resistant organism (MDRO) Infections

  3 years

• Intervention acceptability

  3 years

Study Arms (2)

Prebiotic

EXPERIMENTAL

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.

Drug: Resistant Potato Starch

Placebo

PLACEBO COMPARATOR

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.

Drug: Maltodextrin

Interventions

Resistant Potato Starch DRUG

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.

Also known as: MSPrebiotic

Prebiotic

Maltodextrin DRUG

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.

Also known as: Starch placebo control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ambulatory/not hospitalized at time of enrollment

You may not qualify if:

• Allergy to any ingredient or source material in intervention or placebo product
• Severe gastrointestinal condition that may be exacerbated by high dietary fiber intake (history of bowel obstruction, intestinal strictures, diverticulitis, active inflammatory bowel disease with structuring, gastroparesis, and/or severe gastrointestinal motility disorders)
• Uncontrolled diabetes (hospitalized in previous 5 years due to diabetes)
• Dysphagia
• Fecal microbiome transplant in the last 30 days
• Intestinal surgery in the last 30 days
• Pregnancy or breastfeeding
• Immunosuppression, defined as history of solid organ transplant or as receipt of ablative chemotherapy, steroids at the equivalent of ≥5 mg/day prednisone, antimetabolites, anti-TNF agents, calcineurin inhibitors, or mycophenolate at time of enrollment
• Use of probiotics or fiber supplements in previous 30 days
• Already on a decolonization protocol
• Active infection requiring acute antibiotic treatment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Clostridium Infections; Asymptomatic Infections

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nasia Safdar, MD PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasia Safdar, MD PhD

CONTACT

(608) 280-7007; Nasia.Safdar@va.gov

Julie A Keating, PhD

CONTACT

(608) 256-1901; julie.keating@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either the intervention (resistant potato starch prebiotic) or placebo.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years
• Access Criteria: Written requests for access to the data will be accepted. Data and documentation will be available under a data use agreement (DUA) that provides a commitment to use data for research purposes only, not to attempt to identify participants, to secure data using appropriate computer technology, and to destroy/return data after analyses are complete.

Locations

US (1)