Microbiota Intervention for Parkinson's Disease

(MICRO-PD Trial)

Overseen By Hannah McCarthy Potter, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Francisco

Must be taking: Levodopa

Disqualifiers: Chronic gastrointestinal disease, pregnant, others

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Parkinson's disease by using antibiotics to change their gut bacteria. This could make their medications work better and reduce symptoms. Researchers will study how these changes affect patients' symptoms and overall health.

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 rifaximin safe for use in humans?

Rifaximin, a nonabsorbable antibiotic, has been studied for its effects on gut microbiota and inflammation in Parkinson's disease. The studies suggest that rifaximin is generally well-tolerated and safe, with potential benefits in reducing inflammation and improving motor symptoms in Parkinson's patients. ^{1 2 3 4 5}

How does the drug Rifaximin differ from other treatments for Parkinson's disease?

Rifaximin is unique because it is a nonabsorbable antibiotic that targets gut microbiota, potentially reducing inflammation and protecting the brain's blood barrier, which may help improve motor and memory functions in Parkinson's disease patients. ^{2 3 4 6 7}

What data supports the effectiveness of the drug Rifaximin for Parkinson's Disease?

Research shows that Rifaximin, a nonabsorbable antibiotic, can change gut bacteria and reduce inflammation in Parkinson's Disease. In studies, it improved motor and memory performance in mice and showed potential benefits for patients with higher baseline inflammation. ^{2 5 8 9 10}

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

You are currently taking levodopa for your condition and it is working well for you.

You have Parkinson's disease.

You have Parkinson's disease.

Exclusion Criteria

Pregnant individuals

You have a long-term gastrointestinal (stomach and intestines) disease.

You have taken antibiotics or probiotics recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Analysis

Correlate the microbiome profile with the clinical phenotype of PD and medication response

Not specified

Randomized Controlled Trial

Evaluate the effect of microbiome manipulation on clinical phenotype and medication response

2 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Rifaximin

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Rifaximin

Group II: Placebo Placebo Group 1 Intervention

Matching placebo

Rifaximin is already approved in United States, Canada, European Union, India for the following indications:

Approved in United States as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in Canada as Zaxine for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in European Union as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in India as Ciboz and Xifapill for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Nova Southeastern University

Collaborator

Trials

103

Recruited

12,000+

Gateway Institute for Brain Research

Industry Sponsor

Trials

2

Recruited

140+

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Rifaximin Modifies Gut Microbiota and Attenuates Inflammation in Parkinson's Disease: Preclinical and Clinical Studies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Gut bacterial profiles in Parkinson's disease: A systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Microbiota-mediated effects of Parkinson's disease medications on Parkinsonian non-motor symptoms in male transgenic mice. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Levodopa Initiation on the Gut Microbiota in Parkinson's Disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Gut bacterial tyrosine decarboxylase associates with clinical variables in a longitudinal cohort study of Parkinsons disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dysbiosis in Parkinson's disease might be triggered by certain antibiotics. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Intestinal Decontamination Therapy for Dyskinesia and Motor Fluctuations in Parkinson's Disease. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Gut bacterial composition in a mouse model of Parkinson's disease. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Alterations of the gut microbiota with antibiotics protects dopamine neuron loss and improve motor deficits in a pharmacological rodent model of Parkinson's disease. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

IgA-Biome Profiles Correlate with Clinical Parkinson's Disease Subtypes. [2023]