Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease (NCT05568498) | Clinical Trial Compass
RecruitingPhase 2
Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
Canada60 participantsStarted 2025-01-20
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
✓. Between the ages of 40-80 years
✓. Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
✓. Mild to moderate depression (BDI-II score of 14-28 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 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)
What they're measuring
1
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
Timeframe: 13 weeks
2
Beck Depression Inventory, 2nd Edition (BDI-II)
Timeframe: 13 weeks
3
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)