Cincinnati, Ohio 45219


Purpose:

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.


Study summary:

Parkinson's Disease (PD) patients with motor fluctuations will be screened for the presence of Small Intestinal Bacterial Overgrowth (SIBO) using two hydrogen breath tests. SIBO-positive individuals will be eligible to enroll, and randomized to receive either rifaximin or placebo. This study includes two treatment regimens (including a placebo control), designed so that all patients will receive the active drug at some point during the trial. Motor outcomes will be followed for 3 or 6 months following enrollment, depending on the treatment arm to which the subject has been assigned. The primary endpoint is to assess the effect of rifaximin treatment to decrease "off" time in SIBO-positive PD patients. This pilot study will support the design of a larger, randomized controlled trial investigating the effect of SIBO eradication on reducing motor complications in PD patients with motor fluctuations. The current proposal is designed to demonstrate our ability to detect and treat SIBO in PD patients with motor fluctuations, to inform selection of the best SIBO detection method, to determine the optimal timeline for assessing motor endpoints, and to estimate the duration of benefits after treatment.


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.


NCT ID:

NCT02470780


Primary Contact:

Hilary Perez, PhD
Phone: (513)558-0112
Email: hilary.perez@uc.edu


Backup Contact:

Email: alberto.espay@uc.edu
Alberto Espay, MD
Phone: (513)558-4035


Location Contact:

Cincinnati, Ohio 45219
United States

Hilary Perez, PhD
Phone: 513-558-0112
Email: hilary.perez@uc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.