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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
Awards & highlights
TAP Trial Summary
This trial will study whether an oral probiotic can help relieve anxiety in people with Parkinson's Disease.
Eligible Conditions
- Anxiety
- Parkinson's Disease
TAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parkinson's Anxiety Scale (PAS)
Secondary outcome measures
Beck Depression Inventory (BDI)
Fatigue Severity Scale (FSS)
Montreal Cognitive Assessment
+2 moreTAP Trial 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
1,413 Previous Clinical Trials
2,466,900 Total Patients Enrolled
8 Trials studying Anxiety
2,658 Patients Enrolled for Anxiety
The W. Garfield Weston FoundationUNKNOWN
2 Previous Clinical Trials
90 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients needed for this experiment right now?
"The study, which has an open call for participants, was initially posted on December 10th 2020. The listing was most recently edited on May 24th 2022."
Answered by AI
Has the Probiotic supplement been cleared by the FDA?
"While there is some evidence that Probiotic is safe, it falls short of the amount needed to support efficacy. Consequently, our team has given it a score of 2."
Answered by AI
How can I become a participant in this clinical trial?
"72 individuals suffering from parkinson disease will be recruited for this clinical trial. The applicants that are most likely to be accepted into the study meet the following conditions: being between 40-80 years old, having a Hoehn and Yahr stage between 1-3 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), and finally a willingness to maintain current physical activity levels during study period."
Answered by AI
Is the minimum age requirement for participants 18 years or older?
"To be eligible for this particular clinical trial, applicants must between the ages of 40 and 80. In contrast, there are 192 trials available for patients that are younger than 18 and 962 trials for patients that are older than 65."
Answered by AI
Who else is applying?
What site did they apply to?
Pacific Parkinson's Research Centre
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am a nurse and understand the benefits of research well. Want to help in any studies I can to overcome this disease.
PatientReceived no prior treatments
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