Microbiota Intervention for Parkinson's Disease
(MICRO-PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how altering gut bacteria might help people with Parkinson's disease (PD) manage their symptoms more effectively. Researchers believe gut bacteria can influence the effectiveness of PD medications and may even relate to the disease's symptoms. Participants will receive either the antibiotic rifaximin, which targets gut bacteria, or a placebo to determine if this change can improve PD symptoms and medication effectiveness. Ideal candidates for this trial have Parkinson's disease, experience symptom fluctuations, and are stable on levodopa therapy, a common PD medication. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be stable on levodopa therapy. This suggests you may need to continue your current levodopa treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rifaximin, an antibiotic that remains in the gut, is generally safe for people. Studies involving individuals with Parkinson's disease (PD) have found that rifaximin can alter gut bacteria without causing major side effects. This is reassuring because the FDA has already approved rifaximin for other uses, such as treating traveler's diarrhea, which supports its safety.
In past studies, participants taking rifaximin did not report significant side effects, indicating it was well-tolerated. The drug primarily acts in the gut and minimally enters the bloodstream, likely reducing the risk of systemic side effects. This makes it a promising option for those interested in treatments targeting the gut-brain connection in Parkinson's disease.12345Why do researchers think this study treatment might be promising for Parkinson's disease?
Unlike the standard treatments for Parkinson's disease, which typically focus on managing symptoms with medications like levodopa and dopamine agonists, Rifaximin offers a novel approach by targeting the gut microbiota. Researchers are excited about Rifaximin because it is an antibiotic that could potentially modify gut bacteria, which is believed to play a role in the disease's progression. By altering the microbiota, Rifaximin might address underlying factors contributing to Parkinson's, offering a fresh avenue for treatment beyond symptom management.
What evidence suggests that this trial's treatments could be effective for Parkinson's disease?
Research suggests that rifaximin, which participants in this trial may receive, might help reduce movement problems in people with Parkinson's disease (PD). One study found that PD patients who took rifaximin experienced a noticeable decrease in the severity of their movement issues. Another report showed that rifaximin increased certain beneficial gut bacteria in PD patients, which could be helpful. A small study also indicated that rifaximin reduced movement fluctuations in patients with small intestinal bacterial overgrowth (SIBO), a condition some people with PD have. While some studies have mixed results, these findings suggest that rifaximin could be promising for managing PD symptoms by changing gut bacteria. Participants in this trial may also receive a placebo as part of the study's control arm.12678
Who Is on the Research Team?
Caroline Tanner, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cross-sectional Analysis
Correlate the microbiome profile with the clinical phenotype of PD and medication response
Randomized Controlled Trial
Evaluate the effect of microbiome manipulation on clinical phenotype and medication response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Rifaximin
Rifaximin is already approved in United States, Canada, European Union, India for the following indications:
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
- Traveler's diarrhea
- Irritable bowel syndrome with diarrhea
- Hepatic encephalopathy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Nova Southeastern University
Collaborator
Gateway Institute for Brain Research
Industry Sponsor