Bacillus Subtilis in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Dietary Supplement: Bacillus SubtilisOther: Placebo
- Registration Number
- NCT06487975
- Lead Sponsor
- University of Edinburgh
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bacillus Subtilis Bacillus Subtilis Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10\^9 Colony Forming Units) Placebo 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)
- Primary Outcome Measures
Name Time Method To assess the effect of Bacillus Subtilis on gut microbiome 24 weeks Changes in presence and abundance of Bacillus Subtilis and other bacteria in faeces following probiotic administration versus placebo. Non-parametric tests (such as Wilcoxon signed-rank test and permutational multivariate analysis of variance) will be used for alpha and beta diversity analyses, and to identify genera that have significantly changed in abundance.
To assess the effects of Bacillus Subtilis on blood biomarkers (alpha-synuclein species) 24 weeks Changes in alpha synuclein species following Bacillus Subtilis administration versus placebo measured using α-syn real-time quaking-induced conversion assays
To assess the effects of Bacillus Subtilis on blood biomarkers (sphingolipid profile) 24 weeks Changes in sphingolipids following Bacillus Subtilis administration versus placebo measured using liquid chromatography-mass spectrometry
To assess the effects of Bacillus Subtilis on blood biomarkers (neurofilament light chain) 24 weeks Changes in neurofilament light chain following Bacillus Subtilis administration versus placebo measured using Single Molecule Array assay
To assess the effects of Bacillus Subtilis on blood biomarkers (lipid profile) 24 weeks Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo
To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C) 24 weeks Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo
To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose) 24 weeks Changes in fasting glucose following Bacillus Subtilis administration versus placebo
To assess the effects of Bacillus Subtilis on blood biomarkers (pro-inflammatory cytokines) 24 weeks Changes in pro-inflammatory cytokines following Bacillus Subtilis administration versus placebo measured using V-PLEX Proinflammatory Panel 1 Human Kit
To evaluate the acceptability of Bacillus Subtilis administration in PD patients 24 weeks Descriptive analysis of custom-designed Acceptability Questionnaire which includes four questions on number of missed doses, ease of swallowing, daily dosing schedule, and any other barriers to tablet compliance.
- Secondary Outcome Measures
Name Time Method To evaluate the correlation between changes in gut and blood biomarkers following B. subtilis administration and motor/non-motor symptoms 24 weeks Correlation between Primary Objectives 1 and 2 and motor/non-motor symptoms: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Movement Disorder Society Non-Motor Rating Scale (MDS-NMS), Montreal Cognitive Assessment (MoCA) and Parkinson's Disease Questionnaire (PDQ-39)
Trial Locations
- Locations (2)
Norwegian Centre for Movement Disorders, Stavanger University Hospital
🇳🇴Stavanger, Norway
NHS Lothian
🇬🇧Edinburgh, United Kingdom