Do probiotics improve functions and wellbeing in Parkinson's disease?
Research type
Research Study
Full title
Can a 12-week probiotic intervention improve wellbeing in Parkinson’s Disease? A randomised double-blind placebo-controlled pilot study
IRAS ID
262286
Contact name
Lynne A Barker
Contact email
Sponsor organisation
Sheffield Hallam University
Clinicaltrials.gov Identifier
ER13629003, Faculty ethics approval
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
Parkinson’s Disease (PD) is a neurodegenerative condition that affects motor functions and a range of non-motor abilities. There is no cure and a definitive cause is not yet known. It has a prevalence of 0.3% in the general population and 1–3% in the population over the age of 65 (Nussbaum & Ellis, 2003). Globally, it is the second most common neurodegenerative disorder and due to the lack of early diagnosis and effective therapy, represents a large burden for society and healthcare provision.
The underlying pathology of PD is associated with accumulation of abnormal clumps of alpha-synuclein protein termed Lewy bodies and Lewy neurites in the central nervous system (CNS) that impede the normal function of brain cells. Evidence from animal studies indicates that the production of alpha-synuclein begins in the gut, and gastro-intestinal problems are a common feature of PD.The gut contains millions of micro-organisms termed the microbiome. Over the past decade research findings have identified a complex bidirectional interaction between the gastrointestinal (GI) tract and the central nervous system (CNS), the Gut-Brain axis (Braak et al., 2006). It is now known that the Gut-Brain axis is adversely affected by PD. Recently, probiotics have been proposed as a potential intervention for systemic and neurological conditions by improving microbiome composition (Perez-Pardoa et al., 2017).
The proposed study will pilot a 12-week intervention using Symprove probiotic and placebo and functional measures in PD patients in a randomised double-blind placebo-controlled study with 70 patients. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study.
Symptoms, mood state, quality of life and wellbeing will be measured at baseline and post-intervention. Stool samples will be collected at baseline and 12-weeks, in both study arms, and DNA sequenced to determine microbiome composition.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0153
Date of REC Opinion
11 Jul 2019
REC opinion
Further Information Favourable Opinion