Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Anxiety in Parkinson's Disease With a Multi‐Strain Probiotic (TAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03968133
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
The W. Garfield Weston Foundation
Information provided by (Responsible Party):
Silke Cresswell, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anxiety Dietary Supplement: Probiotic Dietary Supplement: Placebo Phase 2 Phase 3

Detailed Description:

Parkinson's disease (PD) is a complex condition that carries a high burden of neuropsychiatric comorbidities. About a third of individuals living with Parkinson's disease have one or more anxiety disorders, resulting in lower quality of life, greater care dependency, and increased caregiver burden. Gastrointestinal dysfunction is very common in Parkinson's. Constipation is experienced by the vast majority of patients and often manifests years before onset of motor symptoms, symptoms suggestive of irritable bowel syndrome are also commonly found in PD. Increased intestinal permeability has been demonstrated in PD. Impaired intestinal barrier function can lead to chronic systemic low-grade inflammation, which has been strongly associated with mood disorders. Several lines of evidence suggest a link between the gut microbiome and Parkinson's disease.

The microbiome has been linked to anxiety both in human and animal studies. Several studies have found beneficial effects of probiotics on mood disorders in non-PD populations, including stress and depressive behaviour in animal models, and sad mood reactivity and major depressive disorder in humans. Specifically regarding anxiety, probiotics have shown benefits in several animal models; human probiotic trials have demonstrated improvements in psychological distress and anxiety in healthy controls, in mothers experiencing postpartum depression and anxiety and in individuals afflicted with IBS-related anxiety without PD.

In summary, given the high rate of anxiety in PD, the growing evidence that probiotics may improve anxiety and mood disorders in non-PD populations, and the strong links between the gut microbiome and PD, we will carry out a randomized, blinded, placebo-controlled study into the use of a multi-strain probiotic to improve anxiety and Parkinson's disease.

Recruitment: Approximately 72 participants will be randomized to either the probiotic intervention arm or placebo treatment. Participants will mainly be recruited from the Pacific Parkinson's Research Centre movement disorder clinic at the University of British Columbia in Vancouver.

Participants will receive a detailed description of the study and will need to provide informed consent for participation in the study. Participants will be screened for inclusion and exclusion criteria.

Assessments: Clinical assessments of motor function, cognition and neuropsychiatric symptoms will be done before the 12 week intervention phase as well as following after the 12 week intervention with regular check ins during the course of the intervention. Blood samples and stool samples will be collected before and after the intervention.

The primary outcome will be the difference between the probiotic vs. placebo groups in mean Parkinson's Anxiety Scale (PAS) score pre/post-intervention. The primary analysis will be based on intention-to-treat. Secondary analyses for anxiety will include assessing the proportion of participants with a post-intervention PAS of ≤13 in each group. For other secondary outcomes, the between-group difference analysis will be applied to the fatigue, depression, PD motor function, severity (UPDRS I-III) and quality of life scores pre/post intervention, respectively. Adverse events, tolerability and drop-out rates will be registered and overall rates compared between the intervention groups. Furthermore, differences and changes in blood markers and microbiome composition will be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, triple-blind, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Anxiety in Parkinson's Disease With a Multi‐Strain Probiotic - a Randomized, Placebo-controlled Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: Probiotic
Oral probiotic delivered in powdered form.
Other Name: Ecologic® BARRIER 849

Placebo Comparator: Placebo
Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)
Dietary Supplement: Placebo
Oral placebo delivered in powdered form.




Primary Outcome Measures :
  1. Parkinson's Anxiety Scale (PAS) [ Time Frame: 13 weeks ]
    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).


Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: 13 weeks ]
    The BDI is a self reported 21-question multiple-choice self-report inventory on a scale from 0-3.

  2. Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [ Time Frame: 13 weeks ]
    The PDQ-39 is a self reported questionnaire that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living.

  3. Fatigue Severity Scale (FSS) [ Time Frame: 13 weeks ]
    The Fatigue Severity Scale is a self reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders on a scale from 1 (strongly disagree) to 7 (strongly agree).

  4. Montreal Cognitive Assessment [ Time Frame: 13 weeks ]
    The MoCA test is a one-page 30-point administered assessment used for detecting cognitive impairment.

  5. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 13 weeks ]
    The MDS-UPDRS is a clinical assessment of motor and non-motor symptoms in individuals with Parkinson's Disease. It consists of four subscales. Subscales 1, 3, and 4 are administered by a trained individual with subscale 2 being self reported. Each item is rated from 0 to 4.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40-80 years
  • Confirmed diagnosis of Parkinson's disease (based on Queen Square Brain Bank criteria)
  • Mild to moderate PD (Hoehn and Yahr score of 1-3)
  • Anxiety score (PAS) of ≥14

Exclusion Criteria:

  • Atypical parkinsonism
  • Active suicidality
  • Active psychosis
  • Cognitive score (MoCA) of <21
  • BDI score above 28
  • Probiotic and/or antibiotic usage in the past 2 months
  • Regular benzodiazepines usage
  • Regular anti-inflammatory drug usage (e.g. Naproxen, ibuprofen, Aleve)
  • Concurrent psychotherapy or brain stimulation for the treatment of mood disorders
  • Change in anti-depressant within in the last 4 weeks
  • Change in Parkinson 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)
  • Allergy to corn starch or corn
  • Concurrent treatment for Parkinson Disease with Duodopa or Deep Brain Stimulation (DBS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968133


Contacts
Layout table for location contacts
Contact: Petra Uzelman, BSN 6048275373 petra.uzelman@ubc.ca

Locations
Layout table for location information
Canada, British Columbia
Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Petra Uzelman, BSN    6048275373      
Principal Investigator: Silke Appel-Cresswell, MD         
Sponsors and Collaborators
University of British Columbia
The W. Garfield Weston Foundation
Investigators
Layout table for investigator information
Principal Investigator: Silke Appel-Cresswell, MD University of British Columbia

Layout table for additonal information
Responsible Party: Silke Cresswell, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03968133    
Other Study ID Numbers: H18-03083
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silke Cresswell, University of British Columbia:
probiotic
mood
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Anxiety Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders