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Probiotic for Anxiety in Parkinson's Disease (TAP Trial)
Phase 2
Waitlist Available
Led By Silke Appel-Cresswell, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Summary
This trial will study whether an oral probiotic can help relieve anxiety in people with Parkinson's Disease.
Eligible Conditions
- Overactive Bladder
- Anxiety
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Parkinson's Anxiety Scale (PAS)
Secondary study objectives
Beck Depression Inventory (BDI)
Fatigue Severity Scale (FSS)
Montreal Cognitive Assessment
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,395 Total Patients Enrolled
The W. Garfield Weston FoundationUNKNOWN
3 Previous Clinical Trials
150 Total Patients Enrolled
Silke Appel-Cresswell, MDPrincipal InvestigatorUniversity of British Columbia
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 40 and 80 years old.You cannot take natural supplements that may affect depression, like St. John's Wort or passion flower.You have changed your antidepressant or anxiety medication in the last 4 weeks.You have changed your Parkinson's medication in the last 2 weeks.You have atypical symptoms of Parkinson's disease.You are actively having thoughts of harming yourself.Your score on a memory and thinking test is less than 21 when you are in your normal state.You have taken probiotics, sacchromyces boulardii, or antibiotics in the last 3 months.You are currently receiving therapy or brain stimulation for mood disorders.You are currently being treated for Parkinson's disease with Duodopa or Deep Brain Stimulation (DBS).You have a neurological disease other than Parkinson's, such as Alzheimer's disease or multiple sclerosis.You have a weakened immune system due to conditions like AIDS, lymphoma, or long-term use of corticosteroid medication.You have a condition that makes you bleed easily.You are currently sick with a cold or flu, have infections like hepatitis, HIV, or other types of infections.You are allergic to corn starch or corn.You currently have severe mental health issues that might affect your ability to participate in the study.Your score on the BDI-II test is higher than 28 when you are feeling your usual self.You have a serious medical condition that is not stable.You have a history of using drugs or other substances in a harmful way.You have been diagnosed with Parkinson's disease using specific criteria from the Queen Square Brain Bank.You use anti-inflammatory drugs like corticosteroids, naproxen, ibuprofen, or celecoxib more than twice a week. You can use daily 81 mg ASA.You have mild to moderate Parkinson's disease.You have high anxiety scores or have been diagnosed with anxiety by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Probiotic
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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