Modulation of Gut Microbiota by Rifaximin in PD Patients

NCT03958708 | Unknown Phase 1 DMC

• 1 other identifier: N201805044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this clinical trial are to test 1. Whether 1-week rifaximin treatment is able to restore the gut microbiota in a long-term manner in people with Parkinson's disease? 2. Whether the restoration of gut microbiota in people with Parkinson's disease is associated with the reduction of systemic inflammation and circulating exosomal α-synuclein?

Conditions

Parkinson Disease; Inflammation

Keywords

gut microbiota; rifaximin

Outcome Measures

Primary Outcomes (1)

• Change of gut microbiota

  Comparing the gut microbiota analyzed by 16sRNA with baseline

  Immediate after treatment/ 6-month after treatment

Secondary Outcomes (1)

• Blood biomarkers of neuroinflammation and exosomal alpha-synuclein

  6-month after treatment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: Rifaximin 550 MG

Interventions

Rifaximin 550 MG DRUG

Rifaximin 550 MG, TWICE A DAY, FOR 7 DAYS

Treatment Arm

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease.
• Hoen and Yahe stage I or II
• Age between 45-70 years old

You may not qualify if:

• Severe systemic disease (liver cirrhosis greater than Child's A, glomerular filtration rate\<60 ml/min/1.73m2, NYHA class 2 and above, or any active malignancy)
• Past history of following gastrointestinal diseases (inflammatory bowel disease, peptic ulcer with perforation, biliary tract diseases with cholecystectomy, pancreatitis, any gastrointestinal malignancy)
• Regularly prescribed probiotics or fermented food in past six months
• Regularly prescribed antibiotics or metformin in the past six months
• Mini-mental status test below 22 scores.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Inflammation

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Assisstant Professor, Principal Investigator

Model Details: People at early stage of Parkinson's disease

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 22, 2019
• Study Start: May 13, 2019
• Primary Completion: May 12, 2020
• Study Completion: December 1, 2020
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

TW (1)