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Antibiotic
Microbiota Intervention for Parkinson's Disease (MICRO-PD Trial)
Phase 1 & 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Summary
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.
Eligible Conditions
- Parkinson's Disease
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MDS-UPDRS Part III
Percent of OFF time according to home motor diaries
Side effects data
From 2014 Phase 4 trial • 222 Patients • NCT0184258119%
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%
Hyperkalaemia
2%
Bronchitis
2%
Peritonitis bacterial
2%
Liver transplant
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Non-cardiac chest pain
1%
Pneumonia
1%
Sepsis
1%
Fluid overload
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
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
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
2,586 Previous Clinical Trials
15,084,169 Total Patients Enrolled
Nova Southeastern UniversityOTHER
99 Previous Clinical Trials
11,888 Total Patients Enrolled
Gateway Institute for Brain ResearchIndustry Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking levodopa for your condition and it is working well for you.You have Parkinson's disease.You have a long-term gastrointestinal (stomach and intestines) disease.You have taken antibiotics or probiotics recently.People with weakened immune systems.You have Parkinson's disease.You are currently taking levodopa for Parkinson's disease and your symptoms are not changing too much throughout the day.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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