Project Type: Interventional clinical study
Status: Open – recruiting now
About the project: Experimental research in animals has discovered that a specific probiotic, Bacillus subtilis PXN21, can slow and reverse the accumulation of a protein called alpha-synuclein (which is the pathological hallmark of Parkinson’s).
This research study in people with Parkinson’s will evaluate whether Bacillus subtilis PXN21 influences gut bacteria and specific blood proteins in a way that could be relevant to the underlying condition.
Probiotics are regarded as food products and are safe.
What’s involved?: Participants will be randomised to either treatment with B. subtilis PXN21 (once daily capsule) or a visually identical placebo for 24 weeks.
Participants will attend 3 in-person appointments at the Clinical Research Facility at the Western General Hospital. Taxis and transport can be arranged.
During the study, researchers will collect stool samples from both groups of participants to analyse changes in gut microbiome composition. They will also assess clinical features of Parkinson’s such as changes in motor symptoms, cognitive function and daily living.
Who is eligible to take part?: Who can take part? Confirmed Parkinson’s diagnosis, over 50 years old, Parkinson’s movement symptoms for between 1-5 years.
Who cannot take part?: We are not recruiting people who are already taking certain tablets or who have certain co-existing health conditions because it could influence the study findings. We can speak to you about this if you are interested in the study.
For more information: Please contact the Neuroprogressive and Dementia Network Clinical Research team:
Emma Fleming or David Breen
Email: loth.sdcrn@nhs.scot or David.breen@nhs.scot
Tel: 0131 537 3804
Website
https://services.nhslothian.scot/neuroprogressiveanddementianetwork/probiotic/