Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease (ProD)
Parkinson Disease, Depression
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- Between the ages of 40-80 years
- Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
- Mild to moderate depression (clinical diagnosis of mild to moderate depression in the MINI clinical interview and/or BDI-II score of 14-28, and/or IDS-C score of 12-36, and/or QIDS-SR score of 6-15 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 negative pregnancy test results at screening and baseline
- Willingness to maintain current physical activity levels during study period
- English proficiency
Exclusion Criteria:
- Atypical parkinsonism
- Active suicidality
- Active psychosis
- Cognitive score (MoCA) of < 21 in the "ON" state
- Severe depression (BDI-II score > 28 and/or IDS-C score > 36, and/or QIDS-SR score > 15 in the "ON" state)
- Probiotic, saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic containing foods are allowed)
- The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)
- Change in schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks
- Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
- Change in Parkinson's medication within the last 2 weeks
- 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
- A significant immune-compromised condition due to either a health condition or use of an immune suppressant (e.g., AIDS, lymphoma, chemotherapy treatment, patients undergoing long-term systemic corticosteroid or immunosuppressant treatment)
- A known bleeding disorder
- Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
- Allergy to corn starch or corn
- Concurrent treatment for Parkinson's disease with Duodopa
- Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks
- New onset of significant psychiatric symptoms following DBS procedure that are considered likely related
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
- Drug and/or substance abuse
- Claustrophobia inhibiting ability to complete an MRI
- The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. This includes any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a significant language barrier or cognitive impairment
4.2.1 Additional Exclusion Criteria for Magnetic Resonance Imaging (MRI)
The criteria below will also be reviewed with the MRI technologist before any scanning can occur.
Absolute Contraindications:
- Cardiac pacemaker, wires, or defibrillator
- Metal in eye or orbit
- Ferromagnetic aneurysm clip
- Pregnancy
- Makeup tattoos that are not designed to fade over time
- Copper or stainless steel intrauterine device
Relative Contraindications (participation depends on the individual situation):
- Artificial heart valve
- Ear or eye implant
- Brain aneurysm clip
- Implanted electronic device (e.g., drug infusion pump, electrical stimulator)
- Coil, catheter, or filter in any blood vessel
- Orthopedic hardware (artificial joint, plate, screw, rod)
- Shrapnel, bullets, or other metal fragments
- Surgery, medical procedure, or tattoos (including tattooed eyeliner) in the last six weeks
- Other metallic prostheses
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Probiotic
Placebo
Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58; ≥ 2,5*10^9 colony forming unit (CFU)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10^9 CFU/gram) per day.
Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)