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

25. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53705-2254
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
        • Hovedetterforsker:
          • Nasia Safdar, MD PhD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Andre navn:
  • MSPrebiotic
Placebo komparator: 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.
Legemiddel: 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.
Andre navn:
  • Starch placebo control

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Multidrug resistant organism (MDRO) Decolonization
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alpha-1-antitrypsin (AAT) levels
Tidsramme: 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
Tidsramme: 3 years
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
3 years
Changes in gut microbiome metabolites
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Multidrug resistant organism (MDRO) Infections
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

30. september 2030

Datoer for studieregistrering

Først innsendt

11. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

28. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • INFA-002-25F
  • I01RD001117-01-A1 (Annet stipend/finansieringsnummer: VA Office of Research and Development)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

3 years

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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