Investigating the differences in gut bacteria across ageing and in Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson's disease; Neurological - Parkinson's disease; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12621000006842
• Lead Sponsor: Helen Macpherson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-08
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

•50-80 years for both groups (Healthy older and PD groups) and between 18-35 years for the healthy younger adult group
•Presence of PD, as determined through independent neurologist, for PD group. Level of severity (UPDRS stage II and III) will be determined and mild-moderate PD patients will be included. Note: No early onset PD cases to be included in the study, PD diagnosis has to have occurred at 50 years of age or later.
•For healthy older group, no neurological conditions present and no first-degree relatives with PD (determined through self-report questionnaires). No signs of Parkinsonism or symptoms associated with premotor PD (Assessed through the Unified Parkinson’s Disease Rating Scale (UPDRS stages II and III)
•greater than or equal to 24/30 for the healthy older group on the Montreal Cognitive Assessment (MoCA), greater than or equal to 21 for the PD group on the MoCA

For the healthy younger adult group:
•Aged between 18-35 years
•No neurological/neurodegenerative conditions and no first-degree relatives with PD (determined through self-report questionnaires)
•No signs of Parkinsonism or symptoms associated with premotor PD (Assessed through the Unified Parkinson’s Disease Rating Scale (UPDRS stages II and III)
•greater than or equal to 24/30 on the MoCA

Exclusion Criteria

• Taken prebiotics (fibre supplementation, inulin etc.) or probiotics (Over the counter probiotics, , including Yakult or similar products) within previous 3 months
• Gastrointestinal diseases such as Colitis or Crohn’s disease
• Obesity (BMI greater or equal to 30)
• Drugs/Medication including proton-pump inhibitors and antibiotic use (within the previous 3 months)
• Current drug or alcohol abuse
• Conditions precluding TMS (epilepsy, pacemakers, metal implants etc.)
• PD individuals excluded if they have atypical or secondary Parkinsonism. Additional neurological conditions (i.e. stroke, epilepsy etc. will also be exclusions)
• Clinical diagnosis of depression, or a score of greater than 21 (21-30 indicates moderate depression) as assessed through Beck’s Depression Inventory

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alpha-diversity differences of gut bacteria (from faecal sample) between groups, assessed through several alpha-diversity metrics including but not limited to Shannon's, Simpson's, Chao1, Observed Species etc.[Timepoint 0 (baseline assessment)];Beta-diversity differences of gut bacteria (from faecal sample) between groups, assessed through several beta-diversity metrics including but not limited to weighted and unweighted UniFrac principle coordinate analysis, Bray-Curtis dissimilarity etc. [Timepoint 0 (Baseline Assessment)];Absolute gut bacteria abundance differences between groups (assessed through shotgun metagenomic analysis of faecal samples)[Timepoint 0 (Baseline Assessment)]

Secondary Outcome Measures

Name	Time	Method
Sleep, assessed via a self-report sleep diary and actigraphy.[Timepoint 0 (Baseline)];Cognition.<br>Assessed via the Cogstate Brief battery for which a composite score will be calculated.[Timepoint 0 (Baseline).];Diet.<br>Measured through the average of 2 separate 24-hour recalls through the ASA-24.[Timepoint 0 (baseline)];Physical Activity assessed through actigraphy across a 7 day period.[Timepoint 0 (Baseline)];Brain haemodynamics.<br>Measured using fNIRS (Brite 24 system by Artinis) during 1-, 2- and 3-back cognitive tasks. [Timeline 0 (Baseline)];Neurophysiological measures. Transcranial magnetic stimulation will be used pre- and post-a motor training task to investigate neuroplasticity differences across groups.[Timepoint 0 (Baseline)]