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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2024 |
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Main ID: |
NCT02470780 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treating Bacterial Overgrowth in Parkinson's Disease
SIBO-PD |
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Scientific title:
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Treating Bacterial Overgrowth in Parkinson's Disease |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02470780 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of idiopathic PD
- Daily "off" time = 4 hours
- No changes in levodopa or any other dopaminergic medications expected during the
course of the study
- Will be screened for cognitive ability (Montreal Cognitive Assessment score of = 24)
prior to enrollment
- Will be screened for presence of SIBO prior to enrollment
Exclusion Criteria:
- Any comorbid non-PD-associated gastrointestinal (e.g., achlorhydria) or systemic
diseases that may alter absorption or confound the study results
- Exposure to proton pump inhibitors, immunosuppressive drugs, medications that affect
GI motility (such as prokinetics, anticholinergics, and tricyclic antidepressants),
antibiotics or any other drugs that affect the intestinal flora (such as laxatives)
within a month prior to enrollment.
- Prior deep brain stimulation or ablative functional neurosurgery.
- Prior allergy to rifaximin
- Women who are pregnant, lactating, or plan to become pregnant.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Small Intestinal Bacterial Overgrowth
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Rifaximin
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Primary Outcome(s)
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Change in "Off" Time as Measured by Patient Diary
[Time Frame: baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months]
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Change in "Off" Time as Measured by Wireless Computer Monitoring System
[Time Frame: 1, 3, and 6 months]
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Secondary ID(s)
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2015-2175
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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