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Recruiting Phase 2 NCT05568498

Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease

Trial Parameters

Condition Parkinson Disease
Sponsor University of British Columbia
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 40 Years
Max Age 80 Years
Start Date 2025-01-20
Completion 2026-12-30
Interventions
ProbioticPlacebo

Brief 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 12-week multi-strain probiotic treatment or placebo.

Eligibility Criteria

Inclusion Criteria: 1. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria 2. Between the ages of 40-80 years 3. Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state 4. 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) 5. 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 6. Willingness to maintain current physical activity levels during study period 7. English proficiency Exclusion Criteria: 1. Atypical parkinsonism 2. Active suicidality 3. Active psychosis 4. Cognitive score (MoCA) of \< 21 in the "ON" state 5. Severe depression (BDI-II scor

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