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.
| 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 |
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:
Bacillus Subtilis is a spore-forming probiotic bacterium with several properties that make it attractive for neurodegenerative disease research:
Bacillus Subtilis produces short-chain fatty acids (SCFAs) including butyrate, propionate, and acetate through fermentation of dietary fiber:
The trial specifically measures sphingolipid profiles. Bacillus Subtilis influences sphingolipid metabolism through:
Chronic neuroinflammation is a hallmark of Parkinson's disease. Bacillus Subtilis may address this through:
The gut microbiome influences alpha-synuclein aggregation through:
Bacillus Subtilis-derived metabolites may support mitochondrial function:
This trial represents a growing interest in gut-targeted approaches for neurodegenerative diseases:
| Approach | Stage | Mechanism |
|---|---|---|
| Bacillus Subtilis (NCT06487975) | Active | SCFA production, immunomodulation |
| FMT for PD | Phase 2 | Microbiome restoration |
| Targeted Probiotics | Phase 1 | Strain-specific effects |
| Prebiotic Fiber | Research | SCFA enhancement |
Braak H, et al. Staging of brain pathology related to sporadic Parkinson's disease (2003). 2003. ↩︎
Sampson TR, et al. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease (2016). 2016. ↩︎
Powell N, et al. The Transcriptional Repressor BLIMP1 Curbs Pro-Inflammatory Innate Lymphoid Cell Responses (2020). 2020. ↩︎
Bourassa MW, et al. Butyrate and Neuroinflammation: A Review (2016). 2016. ↩︎