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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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19 October 2017 |
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Main ID: |
NCT01662791 |
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Date of registration:
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07/08/2012 |
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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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Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
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Scientific title:
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Weight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial Overgrowth |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01662791 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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John Di Baise, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion criteria: Parkinson's Disease
Exclusion Criteria:
1. Wheelchair-bound, akinetic individuals
2. Tube-fed individuals
3. Presence of dementia
4. Unwilling or unable to complete the tests
5. Allergic or intolerant to rifaximin
6. Presence of chronic upper or lower gastrointestinal disorders that have symptoms that
may be confused with SBBO (e.g., irritable bowel syndrome, inflammatory bowel disease,
celiac disease, functional dyspepsia, gastroparesis, and chronic pancreatitis)
7. Presence of prior surgery on the gastrointestinal tract except cholecystectomy,
appendectomy or herniorrhaphy
8. Presence of severe concomitant acute or chronic medical condition that may interfere
with the completion or interpretation of the test results
9. Women of childbearing potential. Given the age of patients with Parkinson's disease,
we do not anticipate this being a large population.
10. Use of antibiotics within 1 month of breath testing
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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Parkinson's Disease
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Intervention(s)
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Drug: Rifaximin
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Primary Outcome(s)
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Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
[Time Frame: Baseline to 2 hours]
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Secondary Outcome(s)
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PD-specific Quality of Life Questionnaire (PDQ-39)
[Time Frame: baseline]
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PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
[Time Frame: Baseline and 3 months]
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Paffenbarger Physical Activity Questionnaire (PPAQ)
[Time Frame: Baseline]
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Gastrointestinal Symptom Severity Index (GISSI)
[Time Frame: Baseline]
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Hospital Anxiety and Depression Scale (HADS)
[Time Frame: Baseline]
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Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
[Time Frame: baseline, 3 months]
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Weight Change in Case Group After Treatment
[Time Frame: baseline, 3 months]
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Secondary ID(s)
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11-006817
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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