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Treating Bacterial Overgrowth in Parkinson's Disease (SIBO-PD)

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ClinicalTrials.gov Identifier: NCT02470780
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Alberto J. Espay, MD, MSc, University of Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Small Intestinal Bacterial Overgrowth Drug: Rifaximin Drug: Placebo Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treating Bacterial Overgrowth in Parkinson's Disease
Actual Study Start Date : December 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Three-month follow-up 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.

Drug: Placebo
Placebo matching Rifaximin treatment.

Experimental: Six-month follow-up 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.

Drug: Placebo
Placebo matching Rifaximin treatment.




Primary Outcome Measures :
  1. Change in "off" time as measured by patient diary [ Time Frame: 1, 3, and 6 months ]
  2. Change in "off" time as measured by wireless computer monitoring system [ Time Frame: 1, 3, and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470780


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati

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Responsible Party: Alberto J. Espay, MD, MSc, Associate Professor of Neurology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02470780     History of Changes
Other Study ID Numbers: 2015-2175
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents