Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19
研究概览
简要总结
Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)
详细描述
Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline characteristics will be determined, an ileal biopsy, blood, chyme and urine will be collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age equal or above 18 years old
- •Temporary double enterostomy treated by chyme reinfusion as a routine primary care
- •Downstream bowel of at least 25 cm of healthy small bowel, accessible by a stoma, and suitable for chyme reinfusion and ileal biopsy
- •In case of enterocutaneous fistula, diagnosis of fistula origin and localization confirmed by additional medical imaging (computerized tomography/fistulography)
- •Written informed consent.
排除标准
- •Patients with a mental disability
- •Pregnancy or lactation
- •Hepatocellular carcinoma
- •Blood coagulation disorders
- •Shock of any cause
- •Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
结局指标
主要结局
Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19
时间窗: Week 7
次要结局
- Assessment of citrulline plasma levels(Week 7)
- Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels(Week 7)
- Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels(Week 7)
- Assessment of smooth muscle specific (SM) 22 plasma levels(Week 7)
- Assessment of lipopolysaccharide binding protein (LBP) plasma levels(Week 7)
- Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)(Week 7)
- Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels(Week 7)
- Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha)(Week 7)
- Assessment of bile salt composition in plasma(Week 7)
- Assessment of microbiotic profiling(Week 7)
- Effect of chyme reinfusion in patients with a double enterostomy on liver function(Week 7)