Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study

Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study

Patrocinadores

Patrocinador principal: Northwestern University

Colaborador: University of Illinois at Chicago

Fuente Northwestern University
Resumen breve

This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease. It will also evaluate the fiber's effect on the gut microbiome and potential effects on motor function and non-motor functions. Half of the participants will receive resistant maltodextrin and the other half will receive a control substance, maltodextrin.

Descripción detallada

Intestinal microbiota may play in important role in Parkinson's disease (PD). Colonic bacteria play roles in multiple functions including gut motility and secretion of metabolites which can have systemic effects on the body. Recent evidence has shown that people with PD have an altered distribution of gut bacteria that healthy controls. These changes are associated with differences in various metabolites, including butyrate, that are involved in maintaining the gut barrier integrity and even gait and balance function. Microbiota dysbiosis could potentially exacerbate or even contribute to the pathogenesis of PD. Probiotic and dietary interventions may improve gut function and the motor symptoms in PD, but neither have been examined for their effect on the gut microbiome. Prebiotic treatments have been shown to order the microbiome in some populations, but have not been assessed for tolerability or efficacy in PD.

The objective of this study is to examine the safety and tolerability of resistant maltodextrin (RM), a prebiotic non-digestible fiber, and its effect on the microbiome and motor in non-motor symptoms and PD. The investigators will conduct a randomized, parallel-group double-blinded controlled trial assessing RM 50 g daily compared to maltodextrin (an easily digestible glucose polysaccharide) over 4 weeks. Patients will be dosed with 25 g daily for 1 week and then titrated to 50 g daily for the remaining 3 weeks.

The goals of this study include: 1) To determine the safety and tolerability of RM compared to maltodextrin in patients with PD; 2) To determine if RM will remodel the gut microbiome in patients with PD; 3) (exploratory) To determine if RM administration will improve motor and non-motor symptoms in PD.

Estado general Recruiting
Fecha de inicio November 6, 2018
Fecha de Terminación June 30, 2020
Fecha de finalización primaria June 30, 2020
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Adverse events 4 weeks
Resultado secundario
Medida Periodo de tiempo
Gut microbial remodeling 4 weeks
Inscripción 30
Condición
Intervención

Tipo de intervención: Dietary Supplement

Nombre de intervención: Resistant maltodextrin

Descripción: Resistant maltodextrin powder

Etiqueta de grupo de brazo: Resistant Maltodextrin

Tipo de intervención: Dietary Supplement

Nombre de intervención: maltodextrin

Descripción: maltodextrin powder

Etiqueta de grupo de brazo: Maltodextrin

Elegibilidad

Criterios:

Inclusion Criteria:

- Men and women age ≥60 years

- Diagnosis of PD based on United Kingdom PD brain bank criteria, Hoehn and Yahr stage 1-3.

- Stable dose of PD medications for 30 days prior to study and for duration of study

- If used, stable dose of melatonin, sedative/hypnotic or stimulant medications

Exclusion Criteria:

- use of other prebiotic or probiotic treatment for 30 days prior to or during the study

- unstable medical or psychiatric disorder

- history of diabetes mellitus or current use of medication for diabetes

- cognitive impairment based on Montreal Cognitive Assessment (MoCA) <25.

- current or recent (within previous 3 weeks) use of laxatives

- use of antibiotics in the past 30 days

- participation in another clinical trial in the past 30 days.

Género: All

Edad mínima: 60 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Roneil G Malkani Principal Investigator Northwestern Feinberg School of Medicine Department of Neurology
Contacto general

Apellido: Francesca Moroni

Teléfono: 312-503-0018

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Northwestern University Northwestern G University 312-503-1530
Ubicacion Paises

United States

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Northwestern University

Nombre completo del investigador: Roneil Malkani

Título del investigador: Assistant Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Resistant Maltodextrin

Tipo: Experimental

Descripción: Resistant maltodextrin (RM) powder 25 g during days 1-7 and 50g during days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

Etiqueta: Maltodextrin

Tipo: Placebo Comparator

Descripción: Maltodextrin 25g for days 1-7 and 50 g for days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Double blind placebo (maltodextrin) controlled randomized trial

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Descripción de enmascaramiento: participants will be blinded to condition. control condition (maltodextrin) will be used and has identical appearance. investigator and research staff (except pharmacy) will be blinded to condition

Fuente: ClinicalTrials.gov