Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic

Prior treatment

• Anti-inflammatory drug usage more than twice a week (e.g. corticosteroids, naproxen, ibuprofen, celecoxib). Use of daily 81 mg ASA permitted
• Concurrent psychotherapy or brain stimulation for the treatment of mood disorders
• Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
• Change in Parkinson's medication within the last 2 weeks
• Concurrent treatment for Parkinson Disease with Duodopa or Deep Brain Stimulation (DBS)
• Drug and/or substance abuse

Other illness

• Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
• An immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long term corticosteroid treatment)
• A bleeding disorder
• Current illness (for example a cold or flu like symptoms) and infections (for example hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
• Allergy to corn starch or corn
• Unstable medical conditions or serious disease/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes)

Other

• Atypical parkinsonism
• Active suicidality
• Active psychosis
• Cognitive score (MoCA) of <21 in "ON" state
• BDI-II score above 28 in "ON" state
• Probiotic, sacchromyces boulardii and/or antibiotic usage in the past 3 months
• The use of natural health products that affect depression (e.g. St. John's Wort, passion flower)
• Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial

• Confirmed diagnosis of Parkinson's disease based on Queen Square Brain Bank criteria
• Between ages 40-80
• Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
• Anxiety (PAS score ≥14, MDS-UPDRS Part 1.4 score ≥ 2, and/or clinical diagnosis of anxiety based on the MINI clinical interview in the "ON" state)
• Women of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal litigation, barrier methods and double barrier method) and must have a negative urine pregnancy test result at screening and baseline
• Willingness to maintain current physical activity levels during study period