Alzheimer's Disease and Faecal Microbiota Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of participant recruitment [Feasibility]
研究概览
简要总结
The goal of this study is to assess the feasibility and safety of faecal microbiota transplantation for Alzheimer's disease.
详细描述
Alzheimer's disease (AD) is the most common cause of dementia.
Studies suggest that the gut flora may play a role in the development and/or progression of AD. The gut flora is found to be different in AD compared to healthy individuals. There is also support for a link between the gut flora and diseases affecting the brain, including AD.
Stool transplantation is an established medical treatment for Clostridioides difficile infections by restoring the balance of the gut flora. In this study, gut flora (a stool solution) is transferred from a healthy individual to an individual with AD. The stool transplantation is given during a colonoscopy examination of the large bowel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's dementia mild to moderate stage
- •Presence of Alzheimer pathology core 1 biomarkers as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (2024)
- •Capable of giving informed consent
排除标准
- •Contraindications for colonoscopy examination
- •Contraindications for Magnetic Resonance Imaging (MRI)
- •Life expectancy < 1 year
- •Clinical frailty scale 7 or more
- •History of seizure disorder
- •History of brain tumour or intracranial bleed
- •Major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder
- •Alcohol or substance abuse
- •Decompensated heart disease
- •Malignancy
- •Current use of anticoagulant treatment (dual acting oral anticoagulant or warfarin)
- •Pregnant or planning pregnancy
- •Colonic adenomas over 1 cm, tumours or signs of active colitis on colonoscopy
- •Status after colectomy or hemicolectomy
- •Inflammatory bowel disease
- •Immunocompromised individual
- •Receiving biological/antibody treatment
研究组 & 干预措施
Faecal microbiota transplantation (FMT)
Single-group, single-centre, open-label. Intervention: Faecal microbiota transplantation administered via colonoscopy to the right side of the colon.
干预措施: Biological: Preprocessed thawed donor FMT (Biological)
结局指标
主要结局
Rate of participant recruitment [Feasibility]
时间窗: 1 year
Number of weeks needed to include ten participants for study intervention group
Number participants that complete colonoscopy [Feasibility]
时间窗: 1 year
Number of participants that complete colonoscopy
Time used per intervention [Feasibility]
时间窗: 1 year
Time given in hours and minutes of total time used for intervention per participant including colonoscopy and faecal microbiota transplantation.
Number that meet study eligibility [Feasibility]
时间窗: 1 year
Number of participants who are screened for study eligibility. Number who meet inclusion and exclusion criteria.
Number that complete study [Feasibility]
时间窗: Baseline and 3 months after study intervention
Proportion of participants enrolled that complete the study follow-up.
Incidence of treatment-related adverse events and serious adverse events. [Safety]
时间窗: From baseline to 3 months after faecal microbiota transplantation
Incidence of adverse events (AE) and serious adverse events (SAE). AE and SAE are evaluated by review of the medical record, questions of AE and SAE in person or by telephone, and AE and SAE forms.
Engraftment of faecal microbiota transplantation (FMT)
时间窗: baseline and 3 months after study intervention
Comparison of the taxonomic composition of the microbiome in participants faecal samples at baseline and 3 months after FMT, with donor faecal sample. Metagenomic sequencing of faecal samples will be used.
次要结局
- Cognition: Trailmaking Test (TMT)(Baseline and 3 months after study intervention)
- FAS Test of verbal fluency(At baseline and after 3 months after study intervention)
- Cognition: constructional praxis(at baseline and 3 months after study intervention)
- Cognition: Wordlist(Baseline and 3 months after study intervention)
- Cognition: Montreal Cognitive Assessment (MoCA)(Baseline and 3 months after study intervention)
- Cognition: Trailmaking Test (TMT(Baseline and 3 months after study intervention)
- Cognition: Clinical dementia rating scale - sum of boxes (CDR-SB)(Baseline and 3 months after study intervention)
- Cognition: neuropsychiatric inventory (NPI)(Baseline and 3 months after study intervention)
- Changes in Quality of Life(Baseline and 3 months after intervention)
- Cognition: Activities of Daily Living (ADL)(Baseline and 3 months after study intervention)