Clostridium Butyricum for Motor and Non-motor Symptoms in Parkinson's Disease

Clostridium Butyricum for Motor and Non-motor Symptoms in Parkinson's Disease

Trial Overview

| Field | Value |
|-------|-------|
| NCT Number | [NCT06548256](https://clinicaltrials.gov/study/NCT06548256) |
| Status | Recruiting |
| Sponsor | Pusan National University (Korea) |
| Phase | Not specified |
| Intervention | Miyarisan-BM (Clostridium Butyricum Miyairi) |

Mechanism

[Clostridium butyricum](https://en.wikipedia.org/wiki/Clostridium_butyricum) is a butyrate-producing gut bacterium that has been studied for its beneficial effects on gut health and inflammation. The proposed mechanisms in Parkinson's disease include:

Rationale

Clostridium Butyricum for Motor and Non-motor Symptoms in Parkinson's Disease

Trial Overview

| Field | Value |
|-------|-------|
| NCT Number | [NCT06548256](https://clinicaltrials.gov/study/NCT06548256) |
| Status | Recruiting |
| Sponsor | Pusan National University (Korea) |
| Phase | Not specified |
| Intervention | Miyarisan-BM (Clostridium Butyricum Miyairi) |

Mechanism

[Clostridium butyricum](https://en.wikipedia.org/wiki/Clostridium_butyricum) is a butyrate-producing gut bacterium that has been studied for its beneficial effects on gut health and inflammation. The proposed mechanisms in Parkinson's disease include:

Rationale

The [gut-brain axis](/mechanisms/gut-immune-brain-axis-parkinsons) plays a critical role in Parkinson's disease pathogenesis. Many PD patients exhibit gut dysfunction years before motor symptoms appear. Gut inflammation and dysbiosis may contribute to alpha-synuclein aggregation in the enteric nervous system, which then propagates to the central nervous system via the vagus nerve.

Clostridium butyricum supplementation represents a targeted approach to:

• Reduce gut inflammation
• Restore microbiome balance
• Improve gut barrier function
• Potentially slow alpha-synuclein propagation

Butyrate and Neurodegeneration

The Butyrate Molecule

[Butyrate](/mechanisms/short-chain-fatty-acids-neurodegeneration) is a four-carbon short-chain fatty acid (SCFA) produced by bacterial fermentation of dietary fiber in the colon[@butyrate2023]. It serves as:

• Primary energy source for colonocytes
• Histone deacetylase (HDAC) inhibitor: Epigenetic regulation of gene expression
• Anti-inflammatory agent: Modulates immune cell function
• Barrier enhancer: Strengthens gut tight junctions

Butyrate's Effects on the Brain

The mechanisms by which butyrate may influence neurodegenerative processes include:

Clinical Evidence

Preclinical Studies

Multiple preclinical studies support the use of butyrate-producing bacteria in PD models[@gutbrain2024][@microbiome2023]:

• Motor function improvement: Reducedrotarod latency in mouse PD models
• Neuroprotection: Preserved dopaminergic neurons in the substantia nigra
• Gut barrier improvement: Restored intestinal epithelial integrity
• Microbiome restoration: Rebalanced gut bacterial populations

Human Studies

• Reduced fecal butyrate levels in PD patients compared to controls
• Correlation between butyrate-producing bacteria and motor symptoms
• Pilot studies showing probiotic benefits on motor scores

Study Design Details

Primary Endpoints

• Motor assessment: Change in MDS-UPDRS Part III (motor) score
• Non-motor assessment: Non-Motor Symptoms Scale (NMSS)
• Quality of life: PDQ-39

Secondary Endpoints

• Gut microbiome: Changes in fecal bacterial composition
• Inflammatory markers: Serum cytokines
• Butyrate levels: Fecal SCFA concentrations
• Safety: Adverse event monitoring

Comparison with Other Probiotic Approaches

| Probiotic | Mechanism | Evidence | Stage |
|-----------|-----------|----------|-------|
| Clostridium butyricum | Butyrate production | Preclinical | Phase 2 |
| Bacillus subtilis | Protease, butyrate | Preclinical | Phase 2 |
| Lactobacillus | Various | Mixed | Phase 2/3 |
| Multi-strain | Synergistic | Moderate | Phase 3 |

Future Directions

Combination Approaches

Future studies may explore:

• Synbiotic combinations: Prebiotic + probiotic
• Fecal microbiota transplantation (FMT)
• Targeted metabolic therapy: Direct SCFA supplementation

Biomarker Development

• Microbiome signatures: Predict treatment response
• Metabolic markers: Monitor butyrate production
• Inflammatory biomarkers: Track anti-inflammatory effects

Related Pages

• [Gut-Immune-Brain Axis in Parkinson's Disease](/mechanisms/gut-immune-brain-axis-parkinsons)
• [Microbiome-Targeted Interventions for PD](/therapeutics/microbiome-gut-brain-axis-parkinsons)
• [Bacillus Subtilis for PD](/clinical-trials/bacillus-subtilis-pd)
• [Probiotic Depression in PD](/clinical-trials/probiotic-depression-parkinsons-nct05568498)
• [Short-Chain Fatty Acids in Neurodegeneration](/mechanisms/short-chain-fatty-acids-neurodegeneration)

References