Treating Bacterial Overgrowth in Parkinson's Disease

NCT02470780 | Completed Phase 2 Results

• 1 other identifier: 2015-2175
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Three-month follow-up

EXPERIMENTAL

Drug: Rifaximin; Drug: Placebo

Six-month follow-up

EXPERIMENTAL

Drug: Rifaximin; Drug: Placebo

Interventions

Rifaximin DRUG

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.

Six-month follow-up; Three-month follow-up

Placebo DRUG

Placebo matching Rifaximin treatment.

Six-month follow-up; Three-month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Hilary Perez PhD
• Organization: University of Cincinnati/UC Health

perezhe@ucmail.uc.edu

5135582577

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Participants randomized to the drug ended their study participation at 3 months without switching over to a placebo. Those randomized to placebo were switched to the drug after 3 months and followed for another 3 months (6 months total).

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 12, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Locations

US (1)