Sleep Disorders 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 diagnosed with Parkinson's Disease and are classified as Stage 1 on the Hoehn-Yahr scale (an early stage of the condition)
• People who do not have difficulties with communication or language (such as aphasia)
• People who are willing to voluntarily sign a consent form agreeing to take part in the study
• People who do not have dementia and who score above 24 on a standard memory and thinking test (the MMSE)
• People who live in the same home as a healthy spouse or partner
• People who are not currently taking prebiotics, fibre supplements, probiotics, herbal products, or high-dose vitamins or minerals that could affect inflammation

Who may not be able to join:

• People with a history of severe heart, lung, liver, or kidney failure, or who have a primary psychiatric condition, a developmental condition, or another neurological disease
• People who take sedative or sleeping medications
• People who consume more than 200 mg of caffeine per day (roughly equivalent to 2–3 cups of tea or 1 cup of coffee)
• People who smoke or drink alcohol
• People who have had surgery related to their bowel
• People who have a long-term infectious bowel disease
• People who were born with an abnormality of the bowel
• People who have used probiotics, antifungal medications, or antibiotics within the last three months
• People who have an autoimmune disease or a weakened immune system
• People who report using alcohol or drugs within the last three months
• People who are currently using any over-the-counter medications, supplements, foods, or drinks that may affect stress, sleep, thinking, or mood
• People who have difficulty swallowing due to swallowing anxiety, which would prevent them from taking the study supplement
• People receiving treatment for a gut or digestive condition diagnosed by a doctor — unless that condition is constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease (confirm with trial site)
• People who test positive for HIV or Hepatitis B or C
• People who currently have active inflammatory bowel disease, irritable bowel syndrome, colitis, coeliac disease, short bowel syndrome, or who have had a colostomy or colectomy, or who have gastrointestinal fistulas or strictures
• People who have used any antibiotic within the four weeks before the study begins
• People who use enemas or suppositories to manage constipation
• People who already closely follow a Mediterranean diet, as determined by a score above 6 on a standard 14-item assessment tool used before the study starts

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