Multiomics Targeting Microbiome Associated Changes in Stroke Patients (StrokeMicroBiomics)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA
研究概览
简要总结
Preclinical research has established a convincing connection between changes in the gut microbiota composition and stroke outcome. However clinical data on the gut-brain axis, and its chronic characteristics, is sparse. Additional investigations in the context of ischemic stroke regarding the relationship between dysbiosis and functional changes of the microbiome, as characterized by the metabolome, are still required. The StrokeMicroBiomics study will offer insight into these mechanisms and offer new potential targets for therapeutic interventions.
The primary objective is the characterisation of gut dysbiosis in ischemic stroke patients in the acute phase after stroke and during a 3 month follow-up period.
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
详细描述
Results of experimental, preclinical studies suggest that microbiome-targeted may improve stroke outcome as well as stroke-related comorbidities. Yet, clinical trials describing the extent and time course of microbiome changes after stroke are currently not available. Moreover, the impact of post-stroke dysbiosis on metabolic changes and the systemic immunity are unexplored.
Therefore, the primary objective of this trial is the characterization of gut dysbiosis progression in ischemic stroke patients during a 3 month follow-up period .
The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
In order to elucidate the differential impact of lesion size on immune and microbiome homeostasis, separate patient cohorts with mild and severe stroke will be studied.
Furthermore, to control for the effects of temporary focal neurological deficits and stress induced microbiome and immune changes, patients with stroke mimics and transient ischemic attacks (TIA) are being recruited to the control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written consent as submitted and approved to the human subjects review board must be gathered from the participants
- •Participants must be at least 50 years of age
- •For the severe stroke cohort, eligibility is defined by:
- •CT or MRI confirmed ischemic stroke affecting at least 1/3 of the anterior, medial or posterior cerebral arteries cortical coverage
- •NIHSS of at least 10 at time of induction into emergency room
- •Ischemic Stroke occured within the last 7 days
- •For the mild stroke cohort, eligibility is defined by:
- •CT or MRI confirmed ischemic stroke affecting no more than 1/3 of the anterior, medial or posterior cerebral arteries cortical coverage
- •NIHSS between 1 and 10 at time of induction into emergency room
- •Ischemic Stroke occured within the last 7 days
- •For the TIA cohort, eligibility is defined by:
- •CT or MRI confirmed absence of a lesion
- •NIHSS of 0 no more than 24 hours after induction into emergency room
- •TIA occured within the last 7 days
排除标准
- •Pregnancy
- •Diagnosed and malignant Tumor ailment
- •Active, non-stroke related immunosuppression (i.e. HIV)
- •Infection, operative procedure or antibiotics treatment within 4 weeks prior to stroke/TIA
- •Relevant autoimmune disease (i.e Morbus Crohn)
- •Chronic infectious diseases (i.e Hepatitis C)
- •Hemorrhagic Stroke or intracranial bleeding
- •Cerebellar lesions
- •Other neurodegenerative diseases (i.e. Parkinson´s Disease or Alzheimers Dementia)
结局指标
主要结局
Changes from Baseline in the Gut Microbiome Composition at 3 Months post Stroke/TIA
时间窗: 1-7 Days and 90 Days after Stroke
Gut Microbiome Composition is assessed using Shotgun Sequencing
Changes from Baseline of the Gut Metabolome as measured in Blood and Stool at 3 Months post Stroke/TIA
时间窗: 1-7 Days and 90 Days after Stroke
The Metabolome is measured using Mass-Spectometry
Changes from Baseline in key Immune Populations at 3 Months post Stroke/TIA
时间窗: 1-7 Days and 90 Days after Stroke
Immune Populations are measured using Flow Cytometry
次要结局
- CT and (if available) MRI documentation(1-7 days and 90 days after stroke)
- National Institute of Health Stroke Scale (NIHSS)(1-7 days and 90 days after stroke)
- Modified Rankin Score (mRS)(1-7 days and 90 days after stroke)
研究者
Philip William Melton
MD
Ludwig-Maximilians - University of Munich