A Phase 2 interventional study of Probiotic and Placebo in Parkinson Disease and Anxiety, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
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.
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 61 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion criteria
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 (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)
Dietary Supplement: Placebo
Oral probiotic delivered in powdered form.
Also known as: Ecologic® BARRIER 849
Oral placebo delivered in powdered form.
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).
Time frame: 13 weeks
Beck Depression Inventory (BDI)
The BDI is a self reported 21-question multiple-choice self-report inventory on a scale from 0-3.
Time frame: 13 weeks
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
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.
Time frame: 13 weeks
Fatigue Severity Scale (FSS)
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).
Time frame: 13 weeks
Montreal Cognitive Assessment
The MoCA test is a one-page 30-point administered assessment used for detecting cognitive impairment.
Time frame: 13 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Time frame: 13 weeks
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
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