NCT05570929招募中不适用
Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fecal microbiome taxonomy (Shannon-Index)
研究概览
简要总结
This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body-Mass-Index 18,5 - 34,9 kg/m2
- •Planned living kidney donation / transplantation
排除标准
- •Clinically relevant heart, lung, liver, and kidney diseases
- •Postoperative phase
- •Acute infections
- •Vegan diet
- •Change of body weight of more than 10% in the month prior to study entry
- •Known drug or alcohol abuse
结局指标
主要结局
Fecal microbiome taxonomy (Shannon-Index)
时间窗: Change from Baseline at 24 weeks
Measured by 16S amplicon sequencing
次要结局
- Fat free mass(Change from Baseline at 24 weeks)
- Serum short-chain fatty acid concentration(Change from Baseline at 24 weeks)
- Fecal short-chain fatty acid concentration(Change from Baseline at 24 weeks)
- Office systolic blood pressure(Change from Baseline at 24 weeks)
- Functional capacity of gut microbiota(Change from Baseline at 24 weeks)
- Fecal tryptophan metabolites concentration(Change from Baseline at 24 weeks)
- Body fat content(Change from Baseline at 24 weeks)
- Frequency of circulating T-cell subtypes(Change from Baseline at 24 weeks)
- Serum tryptophan metabolites concentration(Change from Baseline at 24 weeks)
- Office diastolic blood pressure(Change from Baseline at 24 weeks)
研究者
Till Schütte
Principle Investigator
Charite University, Berlin, Germany
研究点 (1)
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