NCT04140760

Probiotic Use in Parkinson's Disease

Can a 12-week Probiotic Intervention Improve Wellbeing in Parkinson's Disease? A Randomised Double-blind Placebo-controlled Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Sheffield Hallam University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1. To evaluate the components and processes needed for a full-scale clinical study: recruitment, randomisation, attrition, probiotic use, stool sample collection, microbiome sequencing and behavioural/cognitive measures and determine the feasibility and patient acceptability of these processes to inform a full-scale study in line with NIHR pilot study guidance. 2. To collect pilot data to determine sample size and power, reliability and sensitivity of selected measures, to maximise the findings and minimise patient burden.

Detailed description

The proposed research is a pilot study with 70 participants, 35 in the probiotic and 35 in the placebo arm of the study. The study will investigate the process of conducting randomised, double-blind, placebo-controlled research about probiotic use in Parkinson's Disease patients. The primary aim of the study is to test elements of the study design for a full-scale clinical study: recruitment, randomisation, probiotic use, stool sample collection and DNA sequencing and behavioural/cognitive measures. The secondary aim is to collect pilot data to determine the sample size, Power and appropriateness of measures needed for a full-scale study that maximises findings and minimises patient burden. 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. 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. 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. Data obtained from this pilot study will be used to identify challenges in conducting research using probiotics in patients with Parkinson's Disease and provide a rationale for conducting a full-scale study including information that may reduce or eliminate problems that limit the successful delivery of a full-scale trial. The investigators will make no claims here about any purported clinical effects of the chosen probiotic.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	Symprove	A liquid probiotic
OTHER	Symprove placebo product	An inert placebo

Timeline

• Start date: 2019-08-14
• Primary completion: 2020-03-31
• Completion: 2020-12-22
• First posted: 2019-10-28
• Last updated: 2020-10-22

Locations

1 site across 1 country: United Kingdom