Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT03968133
Eligibility Criteria:
Inclusion Criteria
1. Confirmed diagnosis of Parkinson's disease based on Queen Square Brain Bank criteria
2. Between ages 40-80
3. Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
4. 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)
5. 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
6. Willingness to maintain current physical activity levels during study period
Exclusion criteria
1. Atypical parkinsonism
2. Active suicidality
3. Active psychosis
4. Cognitive score (MoCA) of \<21 in "ON" state
5. BDI-II score above 28 in "ON" state
6. Probiotic, sacchromyces boulardii and/or antibiotic usage in the past 3 months
7. Anti-inflammatory drug usage more than twice a week (e.g. corticosteroids, naproxen, ibuprofen, celecoxib). Use of daily 81 mg ASA permitted
8. The use of natural health products that affect depression (e.g. St. John's Wort, passion flower)
9. Concurrent psychotherapy or brain stimulation for the treatment of mood disorders
10. Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
11. Change in Parkinson's medication within the last 2 weeks
12. 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
13. An immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long term corticosteroid treatment)
14. A bleeding disorder
15. Current illness (for example a cold or flu like symptoms) and infections (for example hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
16. Allergy to corn starch or corn
17. Concurrent treatment for Parkinson Disease with Duodopa or Deep Brain Stimulation (DBS)
18. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
19. Unstable medical conditions or serious disease/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes)
20. Drug and/or substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03968133
Study Brief:
Protocol Section:
NCT03968133