RecruitingPhase 2NCT05568498

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

Sponsor

University of British Columbia

Enrollment

60 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Parkinson Disease PARKINSON DISEASE (Disorder)

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

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria7

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 Criteria22

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
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