Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Completed · Phase 3
Conditions studied: Parkinson's Disease
In brief
The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was that SBBO is an important contributor to the development of weight loss in individuals with PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators performed a prospective, observational case-control study (Part 1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients who experienced significant weight loss while Controls were defined as those PD patients who did not experience significant weight loss.
Key facts
- Study ID
- NCT01662791
- Run by
- Mayo Clinic
- People needed
- 49
- Starts
- 2012-09-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Wheelchair-bound, akinetic individuals
- Tube-fed individuals
- Presence of dementia
- Unwilling or unable to complete the tests
- Allergic or intolerant to rifaximin
- 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)
- Presence of prior surgery on the gastrointestinal tract except cholecystectomy, appendectomy or herniorrhaphy
- Presence of severe concomitant acute or chronic medical condition that may interfere with the completion or interpretation of the test results
- Women of childbearing potential. Given the age of patients with Parkinson's disease, we do not anticipate this being a large population.
- Use of antibiotics within 1 month of breath testing
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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