86 Participants Needed

Microbiota Intervention for Parkinson's Disease

(MICRO-PD Trial)

DR
EB
RP
HM
Overseen ByHannah McCarthy Potter, BA
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, San Francisco
Must be taking: Levodopa
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

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.23467

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.258910

Who Is on the Research Team?

CT

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.
See 1 more

Exclusion Criteria

Pregnant individuals
You have a long-term gastrointestinal (stomach and intestines) disease.
You have taken antibiotics or probiotics recently.
See 1 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Rifaximin
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Xifaxan for:
  • Traveler's diarrhea
  • Irritable bowel syndrome with diarrhea
  • Hepatic encephalopathy
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Zaxine for:
  • Traveler's diarrhea
  • Irritable bowel syndrome with diarrhea
  • Hepatic encephalopathy
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Xifaxan for:
  • Traveler's diarrhea
  • Irritable bowel syndrome with diarrhea
  • Hepatic encephalopathy
๐Ÿ‡ฎ๐Ÿ‡ณ
Approved in India as Ciboz and Xifapill for:
  • 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

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

Rifaximin Modifies Gut Microbiota and Attenuates Inflammation in Parkinson's Disease: Preclinical and Clinical Studies. [2022]
Gut bacterial profiles in Parkinson's disease: A systematic review. [2023]
Microbiota-mediated effects of Parkinson's disease medications on Parkinsonian non-motor symptoms in male transgenic mice. [2023]
Effect of Levodopa Initiation on the Gut Microbiota in Parkinson's Disease. [2022]
Gut bacterial tyrosine decarboxylase associates with clinical variables in a longitudinal cohort study of Parkinsons disease. [2022]
Dysbiosis in Parkinson's disease might be triggered by certain antibiotics. [2021]
Intestinal Decontamination Therapy for Dyskinesia and Motor Fluctuations in Parkinson's Disease. [2021]
Gut bacterial composition in a mouse model of Parkinson's disease. [2018]
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]
IgA-Biome Profiles Correlate with Clinical Parkinson's Disease Subtypes. [2023]
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