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Modulation of Gut Microbiota by Rifaximin in PD Patients

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ClinicalTrials.gov Identifier: NCT03958708
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chien Tai Hong, Taipei Medical University Shuang Ho Hospital

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?

Condition or disease Intervention/treatment Phase
Parkinson Disease Inflammation Drug: Rifaximin 550 MG Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: People at early stage of Parkinson's disease
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modulation of Gut Microbiota by Rifaximin in PD Patients
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 12, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Treatment Arm Drug: Rifaximin 550 MG
Rifaximin 550 MG, TWICE A DAY, FOR 7 DAYS




Primary Outcome Measures :
  1. Change of gut microbiota [ Time Frame: Immediate after treatment/ 6-month after treatment ]
    Comparing the gut microbiota analyzed by 16sRNA with baseline


Secondary Outcome Measures :
  1. Blood biomarkers of neuroinflammation and exosomal alpha-synuclein [ Time Frame: 6-month after treatment ]
    Comparing the blood level of inflammatory/infection markers (TNF-alpha, IL-6, LPS & zonulin) and exosomal alpha-synuclein



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. Past history of following gastrointestinal diseases (inflammatory bowel disease, peptic ulcer with perforation, biliary tract diseases with cholecystectomy, pancreatitis, any gastrointestinal malignancy)
  3. Regularly prescribed probiotics or fermented food in past six months
  4. Regularly prescribed antibiotics or metformin in the past six months
  5. Mini-mental status test below 22 scores.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958708


Locations
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Taiwan
Shuang Ho Hospital Recruiting
New Taipei City, Taiwan
Contact: Chientai Hong, MD, PhD    +886-2-22490088 ext 8112    ct.hong@tmu.edu.tw   
Principal Investigator: Chientai Hong, MD,PhD         
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital

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Responsible Party: Chien Tai Hong, Doctor, Assisstant Professor, Principal Investigator, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03958708     History of Changes
Other Study ID Numbers: N201805044
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chien Tai Hong, Taipei Medical University Shuang Ho Hospital:
gut microbiota
rifaximin
Additional relevant MeSH terms:
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Parkinson Disease
Inflammation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents