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 : October 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Rifaximin Other: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Microbiota Intervention to Change the Response of Parkinson's Disease |
Actual Study Start Date : | July 15, 2019 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | June 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Rifaximin
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Drug: Rifaximin
Rifaximin 550mg orally |
Placebo Comparator: Placebo
Matching placebo
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Other: Placebo
Placebo control |
- 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.

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Parkinson's disease
- Stable on levodopa therapy with fluctuations
Exclusion Criteria:
- Chronic gastrointestinal disease
- Recent antibiotic or probiotic therapy
- Pregnant
- Immunocompromised

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): NCT03575195
Contact: Hannah McCarthy Potter, BA | 415-514-6257 | Hannah.mccarthypotter@ucsf.edu | |
Contact: Ethan Brown, MD | 415-514-6257 | ethan.brown@ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Hannah McCarthy Potter, BA 415-514-6257 Hannah.MccarthyPotter@ucsf.edu |
Principal Investigator: | Caroline Tanner, MD, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03575195 |
Other Study ID Numbers: |
17-22841 |
First Posted: | July 2, 2018 Key Record Dates |
Last Update Posted: | October 27, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Synucleinopathies Neurodegenerative Diseases Rifaximin Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |