Overview

Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Rifamycins
Rifaximin
Criteria
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