|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03958708 |
|
Date of registration:
|
14/05/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Modulation of Gut Microbiota by Rifaximin in PD Patients
|
|
Scientific title:
|
Modulation of Gut Microbiota by Rifaximin in PD Patients |
|
Date of first enrolment:
|
May 13, 2019 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03958708 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Chientai Hong, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+886-2-22490088 |
|
Email:
|
ct.hong@tmu.edu.tw |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion 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.
Age minimum:
45 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson Disease
|
|
Inflammation
|
|
Intervention(s)
|
|
Drug: Rifaximin 550 MG
|
|
Primary Outcome(s)
|
|
Change of gut microbiota
[Time Frame: Immediate after treatment/ 6-month after treatment]
|
|
Secondary Outcome(s)
|
|
Blood biomarkers of neuroinflammation and exosomal alpha-synuclein
[Time Frame: 6-month after treatment]
|
|
Secondary ID(s)
|
|
N201805044
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|