Bacillus subtilis in Parkinson’s_V1.0
Research type
Research Study
Full title
Effects of Bacillus subtilis PXN21 on blood and gut biomarkers in Parkinson’s disease
IRAS ID
312386
Contact name
David P Breen
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Central to the pathology of Parkinson's disease (PD) is the accumulation of α-synuclein (α-syn) aggregates within Lewy bodies in the brain. These protein aggregates have also been demonstrated in the gastrointestinal tract up to 20 years before the onset of PD motor symptoms. PD is currently incurable and new approaches are urgently needed to slow the course of the disease.
We have previously used a well characterised Caenorhabditis elegans (C. elegans) model of PD that overexpresses human α-syn fused to yellow fluorescent protein to assess the effect of 40 human gut bacterial species and probiotics on α-syn aggregation in living animals. When animals carrying this transgene are fed a regular laboratory diet of Escherichia coli, α-syn forms aggregates that can be visualised by fluorescence microscopy. We discovered that Bacillus subtilis (B. subtilis) PXN21 inhibited and reversed α-syn aggregation when fed to the C. elegans model.
Our central hypothesis, based on this pre-clinical work, is that Bacillus subtilis PXN21 (B. Subtilis PXN21) acts from the gut (via the production of metabolites) to protect against α-syn aggregation.
This twin-site study will take place in Edinburgh, Scotland and Stavanger, Norway. Participants will be randomised to receive either B. subtilis PXN21 or matched placebo over 24 weeks in a double blind design. The study aims to measure any changes in gut and blood biomarkers relevant to the proposed mechanism(s) of action of B. subtilis PXN21, as well as evaluating the acceptability of taking regular B. subtilis PXN21 in the PD population. Alongside ongoing animal experiments, this study could pave the way for future research studies to assess the disease modifying potential of B. subtilis PXN21 in PD.
REC name
West of Scotland REC 3
REC reference
22/WS/0100
Date of REC Opinion
4 Aug 2022
REC opinion
Favourable Opinion