Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic

NCT03968133 | Unknown Phase 2

• 1 other identifier: H18-03083
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the use of an oral multi-strain probiotic in the treatment of anxiety in individuals with Parkinson's Disease. Participants will be randomized to either 12-week multi-strain probiotic treatment or placebo.

Conditions

Parkinson Disease; Anxiety

Keywords

probiotic; mood

Outcome Measures

Primary Outcomes (1)

• Parkinson's Anxiety Scale (PAS)

  The PAS is a self reported 12-item scale that has three subscales: persistent anxiety, episodic anxiety, and avoidance behavior; It is rated using a Likert scale (0-4).

  13 weeks

Secondary Outcomes (5)

• Beck Depression Inventory (BDI)

  13 weeks

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

  13 weeks

• Fatigue Severity Scale (FSS)

  13 weeks

• Montreal Cognitive Assessment

  13 weeks

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

  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 Queen Square Brain Bank criteria
• Between ages 40-80
• Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
• Anxiety (PAS score ≥14, MDS-UPDRS Part 1.4 score ≥ 2, and/or clinical diagnosis of anxiety based on the MINI clinical interview 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 a negative urine pregnancy test result at screening and baseline
• Willingness to maintain current physical activity levels during study period

You may not qualify if:

• Atypical parkinsonism
• Active suicidality
• Active psychosis
• Cognitive score (MoCA) of \<21 in "ON" state
• BDI-II score above 28 in "ON" state
• Probiotic, sacchromyces boulardii and/or antibiotic usage in the past 3 months
• Anti-inflammatory drug usage more than twice a week (e.g. corticosteroids, naproxen, ibuprofen, celecoxib). Use of daily 81 mg ASA permitted
• The use of natural health products that affect depression (e.g. St. John's Wort, passion flower)
• Concurrent psychotherapy or brain stimulation for the treatment of mood disorders
• 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
• An immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long term corticosteroid treatment)
• A bleeding disorder
• Current illness (for example a cold or flu like symptoms) and infections (for example hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)

Sponsors & Collaborators

• University of British Columbia: lead
• The W. Garfield Weston Foundation: collaborator

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Publications (1)

• Lam JS, Tosefsky KN, Zhu J, Meng D, Uzelman P, Pio F, Ainsworth NJ, Vila-Rodriguez F, Howard AK, Appel-Cresswell S. Anxiety is associated with increased risk of suicidality in Parkinson's disease. J Parkinsons Dis. 2026 Jan 6:1877718X251410887. doi: 10.1177/1877718X251410887. Online ahead of print.

  PMID: 41493876 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Silke Appel-Cresswell, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

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: May 28, 2019
• First Posted: May 30, 2019
• Study Start: December 10, 2020
• Primary Completion: May 31, 2023
• Study Completion: December 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CA (1)