Status:
ACTIVE_NOT_RECRUITING
Bacillus Subtilis in Parkinson's Disease
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
Helse Stavanger HF
ADM Protexin
Conditions:
Parkinson Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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...
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 s...
Eligibility Criteria
Inclusion
- Diagnosis of Parkinson's disease
- Able to provide written informed consent
- Over 50 years old
- Motor symptom duration over 12 months
- Stable dopaminergic medication regime for at least 3 months
Exclusion
- Use of probiotic supplements and probiotic-fortified foods (such as probiotic drinks and yoghurts) within past 3 months
- Use of antibiotics within past 3 months
- Previous gastrointestinal surgery or chronic organic bowel disorder
- History of clinically significant motor fluctuations
- History of postural instability or falls
- Current smoker
- Known or suspected allergy to probiotics
- Regular use of antacids, proton pump inhibitors, laxatives or anti-diarrheal drugs
- Use of hypoglycaemic or diabetes drugs
- Participation in clinical trial of investigational medicinal product within past 3 months
- Co-morbidities or other factors that, in the opinion of the investigator, make the patient unlikely to comply with study protocol
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06487975
Start Date
May 2 2023
End Date
December 31 2025
Last Update
July 28 2025
Active Locations (2)
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1
Norwegian Centre for Movement Disorders, Stavanger University Hospital
Stavanger, Norway
2
NHS Lothian
Edinburgh, United Kingdom