Treating Bacterial Overgrowth in Parkinson's Disease

Parkinson's Disease Clinical Trial

— SIBO-PD  

Official title:

Treating Bacterial Overgrowth in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470780
• Other study ID #: 2015-2175
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2015
• Est. completion date: August 2017

Study information

• Verified date: February 2024
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Small Intestinal Bacterial Overgrowth

Intervention

Drug:
• Rifaximin
Rifaximin is an antibiotic used to treat SIBO. It is a 7-day course of treatment followed by three or six months of follow-up. This is a placebo-controlled study designed so that all participants will receive the active drug at least once during the study.
• Placebo
Placebo matching Rifaximin treatment.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in "Off" Time as Measured by Patient Diary	OFF time is the time in which levodopa has ceased to be effective and Parkinsonian symptoms reemerge.	baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months
Primary	Change in "Off" Time as Measured by Wireless Computer Monitoring System	This outcome measure was not analyzed due to low subject enrollment as well as poor subject compliance or data quality in some cases.	1, 3, and 6 months