Effects of Bacillus Subtilis on Blood and Gut Biomarkers in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- To assess the effect of Bacillus Subtilis on gut microbiome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To assess the effect of Bacillus Subtilis on gut microbiome
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 24 weeks
Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo
To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C)
时间窗: 24 weeks
Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo
To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- To evaluate the correlation between changes in gut and blood biomarkers following B. subtilis administration and motor/non-motor symptoms(24 weeks)