Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been officially diagnosed with Parkinson's disease using a standard set of diagnostic criteria called the UK Brain Bank criteria
• People aged between 40 and 80 years old
• People with mild to moderate Parkinson's disease, as measured by a standard rating scale (Hoehn and Yahr stage 1–3), assessed when their medication is working well
• People with mild to moderate depression, as measured by a standard questionnaire (BDI-II score of 14–28), assessed when their medication is working well
• Women who could become pregnant must agree to use an approved form of birth control (such as hormonal contraceptives, an IUD, barrier methods, or sterilisation) and must have a negative pregnancy test at the start of the trial
• People who are willing to keep their current level of physical activity the same throughout the study
• People who are proficient in English

Who may not be able to join:

• People who have an atypical form of Parkinsonism (a related but different condition to Parkinson's disease)
• People who are currently experiencing thoughts of suicide
• People who are currently experiencing psychosis (such as hallucinations or delusions)
• People whose cognitive (thinking and memory) score falls below a certain level on a standard test called the MoCA, assessed when their medication is working well
• People with severe depression, as measured by the BDI-II questionnaire (score above 28), assessed when their medication is working well
• People who have taken probiotics, Saccharomyces boulardii supplements, or antibiotics in the past 3 months (note: probiotic-containing foods such as yogurt and kefir are allowed)
• People currently using natural health products that can affect mood, such as St. John's Wort, passion flower, GABA, 5-HTP, kava, bacopa, or essential fatty acids (EFAs)
• People who have changed their psychotherapy schedule or brain stimulation treatment for mood or anxiety in the last 4 weeks
• People who have changed their antidepressant or anti-anxiety medication (including benzodiazepines) in the last 4 weeks
• People who have changed their Parkinson's medication in the last 2 weeks
• People who have a neurological condition other than Parkinson's disease, such as Alzheimer's disease, certain types of dementia, Huntington's disease, brain tumours, multiple sclerosis, seizure disorders, or a significant history of head injury
• People with a serious condition that significantly weakens the immune system, such as AIDS, lymphoma, or those undergoing chemotherapy or long-term steroid or immunosuppressant treatment
• People with a known bleeding disorder
• People who are currently unwell with an illness or infection, such as a cold, flu, hepatitis, HIV, gastroenteritis, or fungal or parasitic infections
• People who are allergic to corn starch or corn
• People who are currently being treated for Parkinson's disease with a medication called Duodopa
• People who have had their Deep Brain Stimulation (DBS) settings changed in the last 4 weeks
• People who have developed significant new psychiatric symptoms that appear to be related to a DBS procedure
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People with unstable or serious medical conditions, such as cancer currently being treated or poorly controlled diabetes
• People with a current drug or substance abuse problem
• People who, in the opinion of the trial investigator, may not be able to follow the study requirements due to language barriers, cognitive difficulties, or other reasons (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.