Microbiota Intervention to Change the Response of Parkinson's Disease

Parkinson Disease Clinical Trial

— MICRO-PD  

Official title:

Microbiota Intervention to Change the Response of Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03575195
• Other study ID #: 17-22841
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 15, 2019
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: Hannah McCarthy Potter, BA
• Phone: 415-514-6257
• Email: Hannah.mccarthypotter[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic gastrointestinal disease
• Recent antibiotic or probiotic therapy
• Pregnant
• Immunocompromised

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Rifaximin
Rifaximin 550mg orally

Other:
• Placebo
Placebo control

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Gateway Institute for Brain Research, Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MDS-UPDRS Part III	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.	Two weeks
Primary	Percent of OFF time according to home motor diaries	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.	Two weeks