Recruiting
Phase 2

Multi-Strain Probiotic

Sponsor:

University of British Columbia

Code:

NCT05568498

Conditions

Parkinson Disease

Depression

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Probiotic

Placebo

Study Details

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)

Study ID

NCT05568498

Start date

Jan 20, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
2. Between the ages of 40-80 years
3. Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
4. Mild to moderate depression (BDI-II score of 14-28 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 score > 28 in the "ON" state)
6. Probiotic, Saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)
7. The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)
8. Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks
9. Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
10. Change in Parkinson's medication within the last 2 weeks
11. 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
12. 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)
13. A known bleeding disorder
14. Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
15. Allergy to corn starch or corn
16. Concurrent treatment for Parkinson's disease with Duodopa
17. Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks
18. New onset of significant psychiatric symptoms following DBS procedure that are considered likely related
19. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
20. Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
21. Drug and/or substance abuse
22. 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Probiotic

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.

placebo comparator: Placebo

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

Interventions

Probiotic

Oral probiotic delivered in powdered form.

Placebo

Oral placebo delivered in powdered form.

Primary outcome measure

  • Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C) [ Time Frame: 13 weeks ]
  • Beck Depression Inventory, 2nd Edition (BDI-II) [ Time Frame: 13 weeks ]
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Locations

Pacific Parkinson's Research Centre

Recruiting

Vancouver, British Columbia, Canada, V6T2B5

Contacts

Principal Investigator:

Silke Appel-Cresswell, MD, FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Parkinsons Disease
  • Depression
  • Probiotics
  • Gut Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-08.