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

NCT ID: NCT03667404

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Parkinson Disease; Intestinal Bacteria Flora Disturbance; Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Resistant Maltodextrin

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.

Group Type: EXPERIMENTAL

Resistant maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Resistant maltodextrin powder

Maltodextrin

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.

Group Type: PLACEBO_COMPARATOR

maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin powder

Interventions

Resistant maltodextrin

Resistant maltodextrin powder

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin

maltodextrin powder

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Roneil Malkani

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roneil G Malkani

Role: PRINCIPAL_INVESTIGATOR

Northwestern Feinberg School of Medicine Department of Neurology

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

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Other Identifiers

STU00207142

Identifier Type: -

Identifier Source: org_study_id