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

2026년 8월 25일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

120

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Wisconsin
      • Madison, Wisconsin, 미국, 53705-2254
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
        • 수석 연구원:
          • Nasia Safdar, MD PhD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • MS프리바이오틱
위약 비교기: 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.
의약품: 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.
다른 이름들:
  • Starch placebo control

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Multidrug resistant organism (MDRO) Decolonization
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Alpha-1-antitrypsin (AAT) levels
기간: 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
기간: 3 years
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
3 years
Changes in gut microbiome metabolites
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Multidrug resistant organism (MDRO) Infections
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VA Office of Research and Development

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2029년 12월 31일

연구 완료 (추정된)

2030년 9월 30일

연구 등록 날짜

최초 제출

2026년 8월 11일

QC 기준을 충족하는 최초 제출

2026년 8월 25일

처음 게시됨 (실제)

2026년 8월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 25일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • INFA-002-25F
  • I01RD001117-01-A1 (기타 보조금/기금 번호: VA Office of Research and Development)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

3 years

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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