Phase 4 Parkinson's Disease Trial, Recruiting

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

Who might be able to join this trial:

For people with Parkinson's disease who also have REM Sleep Behavior Disorder (RBD):

• You are between 40 and 80 years old
• You have been diagnosed with Parkinson's disease according to recognised medical guidelines (2015 criteria)
• Your Parkinson's symptoms are at a mild to moderate stage (stage 3 or below on a standard scale)
• You do not have dementia, confirmed by a standard memory and thinking test
• You do not have depression or anxiety, confirmed by standard rating scales
• You have been diagnosed with REM Sleep Behavior Disorder (a condition where people act out their dreams) through an overnight sleep study, and sleep apnea has been ruled out
• Your Parkinson's and sleep symptoms have been stable for at least one month before joining, with no medication changes in that time
• You have stopped taking certain sleep medications (such as clonazepam or melatonin) for at least one month before joining
• You have not taken probiotics, certain laxatives (like lactulose), or antibiotics for at least two months before joining (or are willing to wait two months after stopping)
• You are willing to follow the study plan and sign a consent form

For people with REM Sleep Behavior Disorder only (without Parkinson's):

• You are between 40 and 80 years old
• You have been diagnosed with REM Sleep Behavior Disorder through an overnight sleep study, and sleep apnea and restless legs syndrome have been ruled out
• You do not have dementia, confirmed by a standard memory and thinking test
• You do not have depression or anxiety, confirmed by standard rating scales
• You have stopped taking certain sleep medications (such as clonazepam or melatonin) for at least one month before joining
• You have not taken probiotics, certain laxatives (like lactulose), or antibiotics for at least two months before joining (or are willing to wait two months after stopping)
• You are willing to follow the study plan and sign a consent form

For healthy volunteers:

• You are between 40 and 80 years old, and your age and gender match the other groups in the study
• You do not have REM Sleep Behavior Disorder or sleep apnea, confirmed by an overnight sleep study, and your sleep screening questionnaire score is low
• You do not have dementia, confirmed by a standard memory and thinking test
• You do not have depression or anxiety, confirmed by standard rating scales
• You do not have severe long-term constipation
• You have not taken probiotics, certain laxatives (like lactulose), or antibiotics for at least two months before joining (or are willing to wait two months after stopping)
• You are willing to follow the study plan and sign a consent form

Who may not be able to join:

• You have a movement disorder other than standard Parkinson's disease, such as multiple system atrophy, progressive supranuclear palsy, or Lewy body dementia (confirm with trial site)
• You have taken probiotics, certain laxatives (like lactulose), or antibiotics within the past two months
• You have changed your Parkinson's medications within the past month, or taken certain sleep medications like clonazepam or melatonin within the past month
• You have certain other serious health conditions, such as Alzheimer's disease, cancer, epilepsy, spinal cord problems, or significant bladder or blood pressure control problems
• You have had a stroke or serious stroke-related complications within the past three months
• You have severe anxiety or depression and are currently taking medication for it
• You have serious heart disease, such as severe heart failure or a heart attack within the past six months
• You have severely reduced liver or kidney function, based on blood test results
• You are pregnant, breastfeeding, or a woman aged 40–60 with a positive pregnancy test
• You are known to be allergic to the study medications (Bifidobacterium triple viable capsules or Bacillus licheniformis) or their ingredients
• You have a history of drug or alcohol dependence
• You are currently taking part in another clinical trial

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