Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-month follow-up | Experimental |
| |
| Six-month follow-up | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin (3-month Follow-up) | Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. |
| FG001 | Placebo Then Rifaximin (6-month Follow-up) | Participants in this group received a 7-day treatment with placebo and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. At the end of the 3-month visit, they were given a 7-day course of Rifaximin and followed for an additional 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
| |||||||||||||
| Phase 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin (3-month Follow-up) | Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. |
| BG001 | Placebo Then Rifaximin (6-month Follow-up) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants in this group completed the study at 3 months after treatment with rifaximin. They were not assessed at 4 and 6 months. | Posted | Mean | Standard Deviation | hours | baseline to 1 month and 3 months; new baseline at 3 months to 4 months and 6 months |
|
During enrollment period (3 months or 6 months, depending on group assignment)
Adverse events related to disease state or disease progression were not collected. Only adverse events related to study interventions were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin | Participants in this group received a 7-day treatment with Rifaximin and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilary Perez PhD | University of Cincinnati/UC Health | 5135582577 | perezhe@ucmail.uc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2017 | Apr 27, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching Rifaximin treatment. |
|
| NOT COMPLETED |
|
Participants in this group received a 7-day treatment with placebo and were followed for three months. Participants were blinded to their treatment assignment until the conclusions of the 3-month visit. At the end of the 3-month visit, they were given a 7-day course of Rifaximin and followed for an additional 3 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OFF time | OFF time is the time levodopa isn't effective and symptoms of Parkinson's disease reemerge. | Mean | Standard Deviation | hours |
|
Participants in this group received a 7-day treatment with placebo and then received rifaximin. |
|
|
| 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. | This outcome measure was not analyzed due to low subject enrollment as well as poor subject compliance or data quality in some cases. No data were collected for this outcome measure. | Posted | 1, 3, and 6 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo | Participants in this group received a 7-day treatment with placebo and were followed for three months. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |