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Antibiotic

Microbiota Intervention for Parkinson's Disease (MICRO-PD Trial)

Phase 1 & 2
Recruiting
Led By Caroline Tanner, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Parkinson's disease
Patients stable on levodopa therapy with fluctuations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Awards & highlights

MICRO-PD Trial Summary

This trial will study whether the gut microbiome in people with Parkinson's disease (PD) correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions.

MICRO-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have Parkinson's disease.
Select...
You are currently taking levodopa for Parkinson's disease and your symptoms are not changing too much throughout the day.

MICRO-PD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MDS-UPDRS Part III
Percent of OFF time according to home motor diaries

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581
19%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Acute respiratory failure
1%
Gastrointestinal haemorrhage
1%
Fluid overload
1%
Hyperglycaemia
1%
Non-cardiac chest pain
1%
Haematemesis
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose

MICRO-PD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Rifaximin
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
2005
Completed Phase 4
~3120

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,712 Total Patients Enrolled
Nova Southeastern UniversityOTHER
89 Previous Clinical Trials
11,557 Total Patients Enrolled
Gateway Institute for Brain ResearchIndustry Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Rifaximin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03575195 — Phase 1 & 2
Parkinson's Disease Research Study Groups: Intervention, Placebo
Parkinson's Disease Clinical Trial 2023: Rifaximin Highlights & Side Effects. Trial Name: NCT03575195 — Phase 1 & 2
Rifaximin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575195 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings available for participants in this experiment?

"Affirmative, the details noted on clinicaltrials.gov indicate that this trial is now enrolling patients. It was first posted in mid-July 2019 and its most recent update came at the end of October 2022. This research initiative requires 86 volunteers to be recruited across a single location"

Answered by AI

What is the total headcount of participants for this research?

"Affirmative. Per the clinicaltrials.gov platform, this medical research is presently seeking participants. The trial was first published on July 15th 2019 and most recently revised October 25th 2022. 86 individuals across 1 research centre must be recruited for the study to move forward."

Answered by AI

What diseases or conditions may be managed with Rifaximin?

"Rifaximin is typically prescribed to manage the reoccurence of clostridium difficile infections, and can also be utilized in treating symptoms such as bacterial infections, irritable bowel syndrome (IBS), and diarrhea."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
~15 spots leftby Mar 2025