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:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03667404
Eligibility Criteria:
Inclusion Criteria:
* Men and women age ≥60 years
* Diagnosis of PD based on United Kingdom PD brain bank criteria, Hoehn and Yahr stage 1-3.
* Stable dose of PD medications for 30 days prior to study and for duration of study
* If used, stable dose of melatonin, sedative/hypnotic or stimulant medications
Exclusion Criteria:
* use of other prebiotic or probiotic treatment for 30 days prior to or during the study
* unstable medical or psychiatric disorder
* history of diabetes mellitus or current use of medication for diabetes
* cognitive impairment based on Montreal Cognitive Assessment (MoCA) \<25.
* current or recent (within previous 3 weeks) use of laxatives
* use of antibiotics in the past 30 days
* participation in another clinical trial in the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03667404
Study Brief:
Protocol Section:
NCT03667404