Bacillus Subtilis in Parkinson's Disease
NCT Number: NCT06487975
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: DIETARY_SUPPLEMENT: Bacillus Subtilis|OTHER: Placebo
Sponsor: University of Edinburgh
Collaborators: Helse Stavanger HF|ADM Protexin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-05-02
Completion Date: 2025-12-31
Locations: Norwegian Centre for Movement Disorders, Stavanger University Hospital, Stavanger, Norway|NHS Lothian, Edinburgh, United Kingdom

Summary:
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.

Primary Outcome Measures: 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., 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, 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, 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, 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, 24 weeks|To assess the effects of Bacillus Subtilis on blood biomarkers (lipid profile), Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo, 24 weeks|To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose), Changes in fasting glucose following Bacillus Subtilis administration versus placebo, 24 weeks|To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C), Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo, 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., 24 weeks
Secondary Outcome Measures: 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), 24 weeks