Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03705520
Brief Summary:
The purpose of this study is to evaluate the microbiome of medicated and non-medicated subjects diagnosed with Parkinson's disease. Where available, in comparison to the microbiome of a healthy spouse or 1st degree relative.
Detailed Description:
First, a cross sectional study where the investigators will compare microbiome composition in subsets of PD and Multiple System Atrophy (MSA) patients whose household control agree to provide stool samples as well. Each household control subject will be evaluated to ensure there is no clinical evidence of neurological disorders including PD. Also, these subjects will complete a 24 hour diet recall questionnaire before stool collection and validated 3 month food frequency questionnaire to collect dietary information similar to PD patients. Each subject (including PD subjects) will complete a smell questionnaire and a sleep questionnaire to determine whether these "control" subjects have loss of smell or have REM sleep disorders because these conditions increase the risk of PD. For assessing smell, investigators will use the UPSIT questionnaire. For assessing REM sleep disorder, investigators will use RBD1Q which consists of a single question, answered "yes" or "no," as follows: "Has the subject ever been told, or suspected themselves that they seem to 'act out their dreams' while asleep (for example, punching, flailing their arms in the air, making running movements, etc.)?"
Second, in the longitudinal study, the investigators will collect stool every 3 months with 3 day diet questionnaire prior to each collection over 12 months and determine microbiome composition over time. Investigators will correlate the microbiome data with PD symptoms, diet and response to treatment and progression of disease. These studies will determine whether disease progression and factors such as PD medications and diet significantly impact microbiome composition. Furthermore, the investigators will determine whether changes in SCFA-producing bacteria and/or abnormal SCFA profiles correlate with severity of PD symptoms.
Study:
NCT03705520
Study Brief:
Protocol Section:
NCT03705520