[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482935":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":30,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":30,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":44,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic","EXPERIMENTAL","Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +\u002F- 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)\u002Fg), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10\\^9 CFU\u002Fgram) per day.",[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Oral probiotic delivered in powdered form.",[9],[26],"Ecologic® BARRIER 849",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Oral placebo delivered in powdered form.",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Matthew Leung, BSc","CONTACT","604-827-1905","Matthew.Leung@ubc.ca",{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},"Annie Kuan","604-827-0576","annie.kuan@ubc.ca",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Pacific Parkinson's Research Centre","RECRUITING","Vancouver","British Columbia","V6T2B5","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-123.11934,49.24966,{"lat":54,"lon":53},[57,58],{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},{"name":59,"role":60,"phone":30,"phoneExt":30,"email":30},"Silke Appel-Cresswell, MD, FRCPC","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Silke Cresswell","Associate Professor","100482935","phase-2-probiotic-treatment-for-depression-and-associated-mood-disorders-in-parkinsons-disease-100482935",false,"NCT05568498","Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease","ProD","Inclusion Criteria:\n\n1. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria\n2. Between the ages of 40-80 years\n3. Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the \"ON\" state)\n4. Mild to moderate depression (BDI-II score of 14-28 in the \"ON\" state)\n5. Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices, vasectomy\u002Ftubal litigation, barrier methods and double barrier method) and must have negative pregnancy test results at screening and baseline\n6. Willingness to maintain current physical activity levels during study period\n7. English proficiency\n\nExclusion Criteria:\n\n1. Atypical Parkinsonism\n2. Active suicidality\n3. Active psychosis\n4. Cognitive score (MoCA) of \\\u003C 21 in the \"ON\" state\n5. Severe depression (BDI-II score \\> 28 in the \"ON\" state)\n6. Probiotic, Saccharomyces boulardii and\u002For antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)\n7. The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)\n8. Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks\n9. Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks\n10. Change in Parkinson's medication within the last 2 weeks\n11. Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumour, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma\n12. 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)\n13. A known bleeding disorder\n14. Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)\n15. Allergy to corn starch or corn\n16. Concurrent treatment for Parkinson's disease with Duodopa\n17. Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks\n18. New onset of significant psychiatric symptoms following DBS procedure that are considered likely related\n19. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial\n20. Unstable medical conditions or serious disease\u002Fconditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)\n21. Drug and\u002For substance abuse\n22. 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","ALL","40 Years","80 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.",[82,83,84],"Parkinson Disease","Depression","PARKINSON DISEASE (Disorder)",[86,83,87,88],"Parkinsons Disease","Probiotics","Gut Microbiome","2026-05-05",{"date":91,"type":92},"2026-05-08","ACTUAL",{"date":94,"type":92},"2025-01-20",{"date":96,"type":76},"2027-12-31",{"name":5,"class":6},1]