Phase 3
N=49
Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01662791 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO) — 2; 12; 2; 9 participants — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO) |
2; 12; 2; 9 | 1.0 |
| SECONDARY PD-specific Quality of Life Questionnaire (PDQ-39) |
23.1; 14.0; 25.0; 18.1; 17.2; 13.2 | 0.235 |
| SECONDARY PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group |
23.1; 27.8; 25.0; 17.7; 17.2; 11.0 | 0.167 |
| SECONDARY Gastrointestinal Symptom Severity Index (GISSI) |
22.6; 14.5; 7.2; 4.5; 8.1; 6.6 | 0.303 |
| SECONDARY Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group |
32.3; 10.0; 12.9; 8.2; 14.5; 4.0 | 0.056 |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
3.5; 3.3; 3.8; 4.0 | 0.872 |
| SECONDARY Weight Change in Case Group After Treatment |
3; 5 | — |
| SECONDARY Paffenbarger Physical Activity Questionnaire (PPAQ) |
848.8; 2253 | — |
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.
Eligibility Criteria
Inclusion criteria: Parkinson's Disease
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01662791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.