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

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ClinicalTrials.gov Identifier: NCT03667404
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Roneil Malkani, Northwestern University

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
Parkinson Disease Intestinal Bacteria Flora Disturbance Dietary Modification 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double 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 : November 6, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 4 weeks ]
    Adverse event frequency and severity based on diary reports, phone calls, and in-person assessments.


Secondary Outcome Measures :
  1. Gut microbial remodeling [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667404


Contacts
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Contact: Francesca Moroni 312-503-0018 francesca.moroni@northwestern.edu
Contact: Roneil Malkani (312) 503-1530 r-malkani@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Northwestern G University    312-503-1530      
Contact: James Sbarboro    (312) 503-1948    james.sbarboro@northwestern.edu   
Sponsors and Collaborators
Northwestern University
University of Illinois at Chicago
Investigators
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Principal Investigator: Roneil G Malkani Northwestern Feinberg School of Medicine Department of Neurology

Publications:

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Responsible Party: Roneil Malkani, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03667404     History of Changes
Other Study ID Numbers: STU00207142
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roneil Malkani, Northwestern University:
Resistant maltodextrin
dietary fiber
gut microbiome
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases