This clinical trial investigates the effects of Bacillus Subtilis supplementation on gut microbiome composition and blood biomarkers in patients with Parkinson's disease. The study is sponsored by the University of Edinburgh with collaborators from Helse Stavanger HF (Norway) and ADM Protexin.
Trial Details
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Bacillus Subtilis for Parkinson's Disease (NCT06487975)
Overview
Mermaid diagram (expand to render)
This clinical trial investigates the effects of Bacillus Subtilis supplementation on gut microbiome composition and blood biomarkers in patients with Parkinson's disease. The study is sponsored by the University of Edinburgh with collaborators from Helse Stavanger HF (Norway) and ADM Protexin.
Trial Details
| Parameter | Value | |-----------|-------| | NCT Number | NCT06487975 | | Title | Effects of Bacillus Subtilis on Blood and Gut Biomarkers in Parkinson's Disease | | Status | Active, Not Recruiting | | Phase | Not Applicable | | Study Type | Interventional | | Enrollment | 48 participants | | Sponsor | University of Edinburgh | | Collaborators | Helse Stavanger HF; ADM Protexin | | Start Date | May 2, 2023 | | Completion Date | December 31, 2025 | | Locations | Stavanger, Norway; Edinburgh, United Kingdom |
Primary Outcome Measures
Gut Microbiome Assessment — To assess the effect of Bacillus Subtilis on gut microbiome composition
Sphingolipid Profile — To assess the effects of Bacillus Subtilis on blood biomarkers (sphingolipid profile)
Pro-inflammatory Cytokines — To assess the effects of Bacillus Subtilis on blood biomarkers (pro-inflammatory cytokines)
Scientific Rationale
Gut-Brain Axis in Parkinson's Disease
The gut-brain axis represents bidirectional communication between the gastrointestinal tract and the central nervous system through neural, hormonal, immunological, and metabolic pathways. In Parkinson's disease, this axis plays a critical role in disease pathogenesis:
Alpha-Synuclein Propagation: Alpha-synuclein pathology may originate in the enteric nervous system and propagate to the central nervous system via the vagal nerve[@braak2003]
Microbiome Alterations: Patients with PD show profound gut microbiome dysbiosis, including reduced microbial diversity and altered composition of beneficial bacteria[@sampson2016]
Inflammatory Pathways: Gut barrier dysfunction ("leaky gut") allows bacterial products to enter systemic circulation, triggering neuroinflammation[@powell2020]
Bacillus Subtilis: Mechanism of Action
Bacillus Subtilis is a spore-forming probiotic bacterium with several properties that make it attractive for neurodegenerative disease research:
1. Spore Formation
Forms highly resistant endospores that survive gastric acidity and reach the intestines
Can be stored at room temperature with long shelf life
Probiotic properties remain stable through processing and storage
2. Short-Chain Fatty Acid Production
Bacillus Subtilis produces short-chain fatty acids (SCFAs) including butyrate, propionate, and acetate through fermentation of dietary fiber:
Butyrate: Primary energy source for colonocytes; maintains gut barrier integrity; exhibits anti-inflammatory properties through histone deacetylase inhibition[@bourassa2016]
Propionate: Gluconeogenesis substrate; reduces cholesterol synthesis; modulates immune function
Acetate: Energy source; influences appetite regulation and lipid metabolism
3. Immunomodulation
Bacillus Subtilis spores can modulate innate and adaptive immune responses
Reduces pro-inflammatory cytokine production (TNF-α, IL-6, IL-1β)
Promotes regulatory T cell differentiation
Enhances intestinal barrier function through tight junction protein expression
[University of Edinburgh Parkinson's Research](https://www.ed.ac.uk/)
[ADM Protexin](https://www.protexin.com/)
References
[Braak H, et al., Staging of brain pathology related to sporadic Parkinson's disease (2003) (2003)](https://pubmed.ncbi.nlm.nih.gov/12610656/)
[Sampson TR, et al., Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease (2016) (2016)](https://doi.org/10.1016/j.cell.2016.11.018)
[Powell N, et al., The Transcriptional Repressor BLIMP1 Curbs Pro-Inflammatory Innate Lymphoid Cell Responses (2020) (2020)](https://doi.org/10.1038/s41590-020-0654-0)
[Bourassa MW, et al., Butyrate and Neuroinflammation: A Review (2016) (2016)](https://doi.org/10.1016/j.neuroscience.2016.03.041)
Unknown, NCT06487975 - Effects of Bacillus Subtilis on Blood and Gut Biomarkers in Parkinson's Disease (n.d.)
Pathway Diagram
The following diagram shows the key molecular relationships involving Bacillus Subtilis for Parkinson Disease (NCT06487975) discovered through SciDEX knowledge graph analysis: