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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 : September 12, 2018
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Roneil Malkani, Northwestern University

Tracking Information
First Submitted Date  ICMJE September 10, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date September 12, 2018
Estimated Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
Adverse events [ Time Frame: 4 weeks ]
Adverse event frequency and severity based on diary reports, phone calls, and in-person assessments.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
Official Title  ICMJE Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Parkinson Disease
  • Intestinal Bacteria Flora Disturbance
  • Dietary Modification
Intervention  ICMJE
  • Dietary Supplement: Resistant maltodextrin
    Resistant maltodextrin powder
  • Dietary Supplement: maltodextrin
    maltodextrin powder
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Resistant maltodextrin
  • 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.
    Intervention: Dietary Supplement: maltodextrin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roneil G Malkani, MD 312-503-1350 r-malkani@northwestern.edu
Contact: James Sbarboro (312) 503-1948 james.sbarboro@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667404
Other Study ID Numbers  ICMJE STU00207142
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roneil Malkani, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE University of Illinois at Chicago
Investigators  ICMJE
Principal Investigator: Roneil G Malkani Northwestern Feinberg School of Medicine Department of Neurology
PRS Account Northwestern University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP