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

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03667404
Collaborator
University of Illinois at Chicago (Other)
30
Enrollment
1
Location
2
Arms
43.8
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Resistant maltodextrin
  • Dietary Supplement: maltodextrin
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind placebo (maltodextrin) controlled randomized trialDouble blind placebo (maltodextrin) controlled randomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study
Actual Study Start Date :
Nov 6, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: Resistant maltodextrin
Resistant maltodextrin powder
Placebo Comparator: 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.

Dietary Supplement: maltodextrin
maltodextrin powder

Outcome Measures

Primary Outcome Measures

  1. Adverse events [4 weeks]

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

Secondary Outcome Measures

  1. Gut microbial remodeling [4 weeks]

    Change in fecal butyrate-producing bacteria based on high-throughput amplicon sequencing of the V4 variable region of the microbial 16s ribosomal ribonucleic acid (RNA) gene.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • University of Illinois at Chicago

Investigators

  • Principal Investigator: Roneil G Malkani, Northwestern Feinberg School of Medicine Department of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Roneil Malkani, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT03667404
Other Study ID Numbers:
  • STU00207142
First Posted:
Sep 12, 2018
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Roneil Malkani, Assistant Professor, Northwestern University
Resistant maltodextrin
dietary fiber
gut microbiome
Parkinson's disease
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Nov 22, 2021