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

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

Tracking Information

• First Submitted Date: June 21, 2018
• First Posted Date: July 2, 2018
• Last Update Posted Date: August 14, 2020
• Actual Study Start Date: July 15, 2019
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Microbiota Intervention to Change the Response of Parkinson's Disease
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

• Drug: Rifaximin
  Rifaximin 550mg orally
• Other: Placebo
  Placebo control

Study Arms

• Experimental: Intervention
  Rifaximin
  Intervention: Drug: Rifaximin
• Placebo Comparator: Placebo
  Matching placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 21, 2018): 86
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: United States

Administrative Information

• NCT Number: NCT03575195
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

• Nova Southeastern University
• Gateway Institute for Brain Research

Investigators

• Principal Investigator: Caroline Tanner, MD, PhD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: August 2020