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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease, Depression, PARKINSON DISEASE (Disorder)

In brief

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.

Key facts

Study ID

NCT05568498

Run by

University of British Columbia

People needed

60

Starts

2025-01-20

Expected to finish

2027-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• 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 the 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 tumour, 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, breastfeeding, 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
• 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

Where it is running

• Pacific Parkinson's Research Centre — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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