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New treatment option for Parkinson Disease
Official title Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
ClinicalTrials.gov ID: NCT05568498
What this study is testing
- What it's testing
- This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- Between the ages of 40-80 years
- Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
- Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
- Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices...
You likely can't join if
- Atypical Parkinsonism
- Active suicidality
- Active psychosis
- Cognitive score (MoCA) of \< 21 in the "ON" state
- Severe depression (BDI-II score \> 28 in the "ON" state)
- Probiotic, Saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)
See the full eligibility criteria
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- Between the ages of 40-80 years
- Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
- Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
- 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)...
- Willingness to maintain current physical activity levels during study period
- English proficiency
- Atypical Parkinsonism
- Active suicidality
- Active psychosis
- Cognitive score (MoCA) of \< 21 in the "ON" state
- Severe depression (BDI-II score \> 28 in the "ON" state)
- Probiotic, Saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)
- The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)
- Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks
- Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
- Change in Parkinson's 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 tumour, progressive supranuclear palsy, seizure disorder, subdural...
- A significant immune-compromised condition due to either a health condition or use of an immune suppressant (e.g., AIDS, lymphoma, chemotherapy treatment, patients undergoing long-term systemic corticosteroid or...
- A known bleeding disorder
- Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
- Allergy to corn starch or corn
- Concurrent treatment for Parkinson's disease with Duodopa
- Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks
- New onset of significant psychiatric symptoms following DBS procedure that are considered likely related
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
- Drug and/or substance abuse
- The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. This includes any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.