Spinal Cord Injury Rehabilitation: Gut Dysbiosis and Immune Biomarkers As Functional Prognosis Tools and New Therapeutic Targets - a Longitudinal Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in intestinal microbiota
研究概览
简要总结
The goal of this study is to investigate the role of gut microbiota, and related immune biomarkers and metabolites, in the functional recovery of spinal cord injury patients during the subacute phase. The main question it aims to answer is:
How does gut microbiota dysbiosis impact functional recovery in subacute SCI patients, in a way that future targeted probiotic interventions may improve SCI outcomes?
详细描述
Background:
Spinal cord injury (SCI) is a devastating condition with no effective cure. Gut dysbiosis and chronic immune dysfunction are common complications that may hinder recovery. This study aims to investigate the role of gut microbiota and related immune biomarkers and metabolites in the functional recovery of SCI patients during the subacute phase. This study hypothesizes that alterations in the gut microbiota and associated immune responses are critical factors influencing recovery trajectories in patients during the subacute phase of SCI.
Therefore, we aim to investigate the intricate relationship between gut microbiota composition, immune biomarkers, and functional outcomes in this population, to develop a probiotic-based therapeutic intervention.
Study Objectives:
- To characterize gut microbiota changes in subacute SCI patients;
- To identify microbiota-based biomarkers for prognosis;
- To correlate gut dysbiosis with systemic inflammation and functional recovery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with traumatic spinal cord injury.
- •Injury occurred less than 6 months ago (subacute phase).
- •Any neurological level of injury (AIS A-D).
排除标准
- •Use of probiotics or immunomodulatory drugs in the last month.
- •Major gastrointestinal surgery in the last 5 years.
- •Active gastrointestinal diseases or other CNS diseases.
结局指标
主要结局
Change in intestinal microbiota
时间窗: From hospital admission until to one-year post-injury
Microbiota relative abundance of different taxonomic levels to estimate change in alpha-diversity (diversity within different samples from the same individual) and in beta-diversity (diversity between groups) from hospital admission to 1-year post-injury
Change in functional independence from hospital admission to 1-year post-injury
时间窗: From hospital admission until to one-year post-injury
Change in functional independence, as measured by the Spinal Cord Independence Measure, 4th version (SCIM IV) and by Functional Independence Measure (FIM), from hospital admission to 1-year post-injury.
Change in neuromotor impairment from hospital admission to 1-year post-injury
时间窗: From hospital admission until to one-year post-injury
Change in the total ASIA Impairment Scale (AIS) motor score from hospital admission to 1-year post-injury.
次要结局
- Change in bowel function from hospital admission to 1-year post-injury(From hospital admission until to one-year post-injury)
- Change in immunological and inflammation biomarkers(From hospital admission until to one-year post-injury)
- Change in gut microbiota-produced metabolites(From hospital admission until to one-year post-injury)