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Microbiota Intervention to Change the Response of Parkinson's Disease (MICRO-PD)

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ClinicalTrials.gov Identifier: NCT03575195
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : August 14, 2020
Sponsor:
Collaborators:
Nova Southeastern University
Gateway Institute for Brain Research
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • MDS-UPDRS Part III [ Time Frame: Two weeks ]
    The Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a validated scale that quantifies many of the symptoms and signs of Parkinson's disease. Part III in particular focuses on the motor symptoms of Parkinson's disease through a neurologic exam. The exam is often performed when medications are held for 8-12 hours (the "OFF" state) and again when medications are given and providing therapeutic benefit (the "ON" state), and the difference between scores is calculated. The scale goes from a minimum of 0 to a maximum of 132. There is no specific cutoff, but a higher score indicates a higher severity of symptoms. The trial will examine the change in the MDS-UPDRS Part III both OFF and ON medication after the intervention.
  • Percent of OFF time according to home motor diaries [ Time Frame: Two weeks ]
    Patients with Parkinson's disease often have times where levodopa is providing therapeutic benefit and times when it is not. "OFF" time indicates the times of day where levodopa therapy is not providing therapeutic benefit. An outcome of the trial will be the change in medication OFF time that the participant experiences at home, according to motor diaries.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbiota Intervention to Change the Response of Parkinson's Disease
Official Title  ICMJE Microbiota Intervention to Change the Response of Parkinson's Disease
Brief Summary The clinical phenotype of Parkinson's disease (PD) is quite variable, as is the response to and side effects from medications. While many patients respond to carbidopa/levodopa early on, motor fluctuations and dyskinesias can become a problem as the condition progresses, causing significant impairment in function and quality of life. The gut microbiome is of increasing interest in PD, potentially contributing to pathophysiology and clinical phenotype. Furthermore, gut bacteria are capable of metabolizing levodopa, which may decrease its ability to reach the central nervous system and could explain the variable effect seen clinically. Altering the population of drug-metabolizing bacteria could improve the clinical symptoms of PD and the benefit seen with medications. The investigators hypothesize that the gut microbiome in people with PD correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions. The investigators propose a two-part clinical trial. First, a cross-sectional analysis will correlate the microbiome profile with (a) the clinical phenotype of PD and (b) medication response. Second, a randomized, controlled trial, will evaluate the effect of microbiome manipulation on clinical phenotype and medication response. The investigators plan to reduce the level of bacteria through antibiotic use, resetting the potentially disadvantageous microbiome population. Outcomes will include changes in clinical symptoms, alterations in the the microbiome, and changes in serum markers of inflammation. This thorough characterization will broaden our understanding of the gut-brain axis significantly in PD in clinically relevant ways that have yet to be explored.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Rifaximin
    Rifaximin 550mg orally
  • Other: Placebo
    Placebo control
Study Arms  ICMJE
  • Experimental: Intervention
    Rifaximin
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   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: June 21, 2018)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parkinson's disease
  • Stable on levodopa therapy with fluctuations

Exclusion Criteria:

  • Chronic gastrointestinal disease
  • Recent antibiotic or probiotic therapy
  • Pregnant
  • Immunocompromised
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Danilo Romero, BS 415-514-6257 danilo.romero@ucsf.edu
Contact: Ethan Brown, MD 415-514-6257 ethan.brown@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575195
Other Study ID Numbers  ICMJE 17-22841
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Nova Southeastern University
  • Gateway Institute for Brain Research
Investigators  ICMJE
Principal Investigator: Caroline Tanner, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2020

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