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

NCT03667404 | Active Not Recruiting Phase 2

• 1 other identifier: STU00207142
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Intestinal Bacteria Flora Disturbance; Dietary Modification

Keywords

Resistant maltodextrin; dietary fiber; gut microbiome; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse event frequency and severity based on diary reports, phone calls, and in-person assessments.

  4 weeks

Secondary Outcomes (1)

• Gut microbial remodeling

  4 weeks

Study Arms (2)

Resistant Maltodextrin

EXPERIMENTAL

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.

Dietary Supplement: Resistant maltodextrin

Maltodextrin

PLACEBO COMPARATOR

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.

Dietary Supplement: maltodextrin

Interventions

Resistant maltodextrin DIETARY_SUPPLEMENT

Resistant maltodextrin powder

Resistant Maltodextrin

maltodextrin DIETARY_SUPPLEMENT

maltodextrin powder

Maltodextrin

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Parkinson Disease

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roneil G Malkani

  Northwestern Feinberg School of Medicine Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double blind placebo (maltodextrin) controlled randomized trial

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: November 6, 2018
• Primary Completion: June 30, 2022
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)