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| Name | Class |
|---|---|
| Helse Stavanger HF | OTHER_GOV |
| ADM Protexin | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacillus Subtilis | Experimental | Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10^9 Colony Forming Units) |
|
| Placebo | Placebo Comparator | 1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus Subtilis | Dietary Supplement | Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10^9 Colony Forming Units) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Bacillus Subtilis on gut microbiome | 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. | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (sphingolipid profile) | Changes in sphingolipids following Bacillus Subtilis administration versus placebo measured using liquid chromatography-mass spectrometry | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (pro-inflammatory cytokines) | Changes in pro-inflammatory cytokines following Bacillus Subtilis administration versus placebo measured using V-PLEX Proinflammatory Panel 1 Human Kit | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (neurofilament light chain) | Changes in neurofilament light chain following Bacillus Subtilis administration versus placebo measured using Single Molecule Array assay | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (alpha-synuclein species) | Changes in alpha synuclein species following Bacillus Subtilis administration versus placebo measured using α-syn real-time quaking-induced conversion assays | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (lipid profile) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the correlation between changes in gut and blood biomarkers following B. subtilis administration and motor/non-motor symptoms | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Breen, MBChB | NHS Lothian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian Centre for Movement Disorders, Stavanger University Hospital | Stavanger | Norway | ||||
| NHS Lothian |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Other | 1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis) |
|
Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo
| 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose) | Changes in fasting glucose following Bacillus Subtilis administration versus placebo | 24 weeks |
| To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C) | Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo | 24 weeks |
| To evaluate the acceptability of Bacillus Subtilis administration in PD patients | 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. | 24 weeks |
| 24 weeks |
| Edinburgh |
| United Kingdom |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |