Phase 3
N=4
Treating Bacterial Overgrowth in Parkinson's Disease
Parkinson's Disease · Small Intestinal Bacterial Overgrowth
Bottom Line
View on ClinicalTrials.gov: NCT02470780 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in "Off" Time as Measured by Patient Diary — -1.4; -2.8; -0.9; -2.0 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rifaximin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in "Off" Time as Measured by Patient Diary |
-1.4; -2.8; -0.9; -2.0; -1.4; -2.2 | — |
| PRIMARY Change in "Off" Time as Measured by Wireless Computer Monitoring System |
— | — |
Summary
This study investigates the effect of treating Small Intestinal Bacterial Overgrowth (SIBO) in patients with Parkinson's Disease (PD). It will test the hypothesis that treating SIBO with the antibiotic rifaximin will improve motor complications in previously SIBO-positive PD patients.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02470780). 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.