NCT06487975

Bacillus Subtilis in Parkinson's Disease

Effects of Bacillus Subtilis on Blood and Gut Biomarkers in Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bacillus Subtilis	Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10\^9 Colony Forming Units)
OTHER	Placebo	1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis)

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-03-05
• Completion: 2025-11-20
• First posted: 2024-07-05
• Last updated: 2026-04-08

Locations

2 sites across 2 countries: Norway, United Kingdom