A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization (MDRO-Fiber)
25 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nasia Safdar, MD PhD
- Número de teléfono: (608) 280-7007
- Correo electrónico: Nasia.Safdar@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Julie A Keating, PhD
- Número de teléfono: 12542 (608) 256-1901
- Correo electrónico: julie.keating@va.gov
Ubicaciones de estudio
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53705-2254
- William S. Middleton Memorial Veterans Hospital, Madison, WI
-
Investigador principal:
- Nasia Safdar, MD PhD
-
Contacto:
- Nasia Safdar, MD PhD
- Número de teléfono: (608) 280-7007
- Correo electrónico: Nasia.Safdar@va.gov
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
Otros nombres:
|
|
Comparador de placebos: 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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Multidrug resistant organism (MDRO) Decolonization
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Alpha-1-antitrypsin (AAT) levels
Periodo de tiempo: 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
Periodo de tiempo: 3 years
|
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
|
3 years
|
|
Changes in gut microbiome metabolites
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Multidrug resistant organism (MDRO) Infections
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nasia Safdar, MD PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
30 de septiembre de 2030
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INFA-002-25F
- I01RD001117-01-A1 (Otro número de subvención/financiamiento: VA Office of Research and Development)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
3 years
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .