Modulation of Gut Microbiota by Rifaximin in PD Patients
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ClinicalTrials.gov Identifier: NCT03958708 |
Recruitment Status : Unknown
Verified May 2019 by Chien Tai Hong, Taipei Medical University Shuang Ho Hospital.
Recruitment status was: Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease Inflammation | Drug: Rifaximin 550 MG | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Arm |
Drug: Rifaximin 550 MG
Rifaximin 550 MG, TWICE A DAY, FOR 7 DAYS |
- Change of gut microbiota [ Time Frame: Immediate after treatment/ 6-month after treatment ]Comparing the gut microbiota analyzed by 16sRNA with baseline
- 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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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
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 |
Responsible Party: | Chien Tai Hong, Doctor, Assisstant Professor, Principal Investigator, Taipei Medical University Shuang Ho Hospital |
ClinicalTrials.gov Identifier: | NCT03958708 |
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 |
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 |
gut microbiota rifaximin |
Parkinson Disease Inflammation Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Synucleinopathies Neurodegenerative Diseases Pathologic Processes Rifaximin Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |