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A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization (MDRO-Fiber)

25 augustus 2026 bijgewerkt door: VA Office of Research and Development
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Multidrug resistant organisms (MDROs) are resistant to antimicrobials and cause difficult to treat infections. MDRO infections thus lead to increased morbidity and mortality, increased length of stay, and higher medical costs. Colonization with an MDRO is also a risk factor for future infection. While decolonization of the skin is a straightforward and commonly used practice to prevent MDRO infections, gut colonization with MDROs is also a major risk factor but is much more difficult to modify. There is a critical gap in identification of effective, inexpensive, and easy to use interventions to reduce MDRO colonization and promote a healthy gut microbiome to reduce MDRO infections.

This project will address a novel approach to prevention: use of a dietary fiber prebiotic that is easily administered as a dietary supplement, inexpensive, and well-tolerated. While evidence suggests that prebiotics and dietary fiber have potential to promote healthy gut microbiomes and reduce MDRO colonization in the gut, there have not yet been any published studies in humans on the effect of dietary fiber prebiotic in reducing MDRO colonization.

The investigators will conduct a randomized, double-blind, placebo-controlled phase II clinical trial in 120 Veterans with a history of MDRO colonization and infection. Veterans will be randomized to a 5-week intervention period of either a dietary fiber intervention (resistant potato starch) or placebo. Participants will submit weekly stool samples during the intervention period, and one follow-up stool sample 3 months after completing treatment. Stool samples will be tested for presence of MDROs (primary outcome), and shotgun metagenomic sequencing and targeted metabolomics will be done to evaluate the gut microbiome (secondary outcomes: changes in metabolites and composition of the gut microbiome). Participants will also answer surveys about their experience with the intervention, including ease of use and tolerability.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53705-2254
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
        • Hoofdonderzoeker:
          • Nasia Safdar, MD PhD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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
  • Ambulatory/not hospitalized at time of enrollment

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Prebiotic
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.
Geneesmiddel: 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.
Andere namen:
  • MSprebiotisch
Placebo-vergelijker: Placebo
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.
Geneesmiddel: 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.
Andere namen:
  • Starch placebo control

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Multidrug resistant organism (MDRO) Decolonization
Tijdsspanne: 3 years
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Alpha-1-antitrypsin (AAT) levels
Tijdsspanne: 3 years
Changes in fecal AAT levels. AAT has been used successfully as a biomarker for intestinal permeability with higher concentrations of AAT in the gut indicating a leaky gut.
3 years
Gut microbiome composition
Tijdsspanne: 3 years
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
3 years
Changes in gut microbiome metabolites
Tijdsspanne: 3 years
Gut microbiome metabolites (short-chain fatty acids, secondary-bile acid producers) will be identified through next-generation sequencing technology and both targeted and untargeted metabolomics.
3 years

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Multidrug resistant organism (MDRO) Infections
Tijdsspanne: 3 years
Changes in infection rates with one or more of the MDROs of interest: C. difficile, Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and/or multi-drug resistant Enterobacteriaceae (MDRE)
3 years
Intervention acceptability
Tijdsspanne: 3 years
A written questionnaire will be given to assess participants' experience with the fiber products. The questionnaire will include statements where participants are asked to rate their agreement with the statement, with responses on a 5-point Likert scale (1-Strongly Disagree to 5-Strongly Agree). Higher scores will indicate higher acceptability of the product.
3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

30 september 2030

Studieregistratiedata

Eerst ingediend

11 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INFA-002-25F
  • I01RD001117-01-A1 (Ander subsidie-/financieringsnummer: VA Office of Research and Development)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

3 years

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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