The aim of this study is to evaluate whether the administration of Bacillus Subtilis influences gut and blood biomarkers relevant to the proposed mechanism(s) of action, as well as being acceptable as a regular supplement for people with Parkinson's disease.
Following informed consent, participants will undergo screening. If eligible, they will be invited to attend a baseline visit (week 0) to complete clinical assessments and provide a faecal and blood sample before starting their assigned intervention. Each participant will be randomised 1:1 to visually identical capsules containing either Bacillus Subtilis or placebo to be taken for 24 weeks. Telephone follow-up will be performed at week 8 to ensure compliance and answer any participant questions. Repeat clinical assessments and faecal/blood sample collection will take place at weeks 24 (treatment end date) and 36 (to assess longevity of biomarker changes after the intervention has stopped). Faecal samples will be collected at home within seven days prior to the clinic visits and brought to the appointment. Microbiota composition in faecal samples and blood biomarkers will be analysed in participant samples. Motor and non-motor symptom rating scales will also be administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
26
Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10\^9 Colony Forming Units)
1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis)
Norwegian Centre for Movement Disorders, Stavanger University Hospital
Stavanger, Norway
NHS Lothian
Edinburgh, United Kingdom
To assess the effect of Bacillus Subtilis on gut microbiome
Changes in presence and abundance of Bacillus Subtilis and other bacteria in faeces following probiotic administration versus placebo. Non-parametric tests (such as Wilcoxon signed-rank test and permutational multivariate analysis of variance) will be used for alpha and beta diversity analyses, and to identify genera that have significantly changed in abundance.
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (sphingolipid profile)
Changes in sphingolipids following Bacillus Subtilis administration versus placebo measured using liquid chromatography-mass spectrometry
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (pro-inflammatory cytokines)
Changes in pro-inflammatory cytokines following Bacillus Subtilis administration versus placebo measured using V-PLEX Proinflammatory Panel 1 Human Kit
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (neurofilament light chain)
Changes in neurofilament light chain following Bacillus Subtilis administration versus placebo measured using Single Molecule Array assay
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (alpha-synuclein species)
Changes in alpha synuclein species following Bacillus Subtilis administration versus placebo measured using α-syn real-time quaking-induced conversion assays
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (lipid profile)
Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo
Time frame: 24 weeks
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To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose)
Changes in fasting glucose following Bacillus Subtilis administration versus placebo
Time frame: 24 weeks
To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C)
Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo
Time frame: 24 weeks
To evaluate the acceptability of Bacillus Subtilis administration in PD patients
Descriptive analysis of custom-designed Acceptability Questionnaire which includes four questions on number of missed doses, ease of swallowing, daily dosing schedule, and any other barriers to tablet compliance.
Time frame: 24 weeks
To evaluate the correlation between changes in gut and blood biomarkers following B. subtilis administration and motor/non-motor symptoms
Correlation between Primary Objectives 1 and 2 and motor/non-motor symptoms: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Movement Disorder Society Non-Motor Rating Scale (MDS-NMS), Montreal Cognitive Assessment (MoCA) and Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 24 weeks