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

NCT05568498 | Recruiting Phase 2

• 1 other identifier: H17-01853
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 a 12-week multi-strain probiotic treatment or placebo intervention.

Conditions

Parkinson Disease; Depression; PARKINSON DISEASE (Disorder)

Keywords

Parkinsons Disease; Depression; Probiotics; Gut Microbiome

Outcome Measures

Primary Outcomes (3)

• Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)

  The Inventory for Depressive Symptomatology is a measure of depressive signs and symptoms administered by a trained clinician. The score range is 0-84 points, with a higher score indicating greater levels of depressive symptomatology.

  13 weeks

• Beck Depression Inventory, 2nd Edition (BDI-II)

  The Beck Depression Inventory is a self-reported 21-question multiple-choice self-report inventory on a scale from 0-63. A higher score indicates greater characteristic attitudes and symptoms of depression. BDI-II is also used as a screening item for mild to moderate depression for this study.

  13 weeks

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

  QIDS-SR is a 16-item, self-administered questionnaire used to assess the severity of depressive symptoms over the past 7 days, based on DSM-IV criteria. QIDS-SR is a shortened version of IDS-C, but QIDS-SR is self-rated (filled in the form of a questionnaire) and IDS-C is clinician-rated (administered as a clinical assessment), so using both assessments allows us to incorporate both self-rated and clinician-rated measures. The score range is 0-27 points, with a higher score indicating greater levels of depressive symptomatology.

  13 weeks

Secondary Outcomes (7)

• Fatigue Severity Scale (FSS)

  13 weeks

• Montreal Cognitive Assessment (MoCA)

  13 weeks

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  13 weeks

• Parkinson's Anxiety Scale (PAS)

  13 weeks

• Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

  13 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- 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)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10\^9 CFU/gram) per day.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Oral probiotic delivered in powdered form.

Also known as: Ecologic® BARRIER 849

Probiotic

Placebo DIETARY_SUPPLEMENT

Oral placebo delivered in powdered form.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T2B5, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Matthew Leung, BSc

CONTACT

604-827-1905; Matthew.Leung@ubc.ca

Annie Kuan

CONTACT

604-827-0576; annie.kuan@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, triple-blind, placebo-controlled study

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: October 5, 2022
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)