Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
研究概览
简要总结
Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy
详细描述
Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.
BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned elective cholecystectomy
排除标准
- •small bowel resection
- •right sided hemicolectomy
- •known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
- •pregnancy
- •wish for pregnancy within next three months
- •allergy to eggs
- •allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)
- •acute cholecystitis within two months
- •chronic cholecystitis
- •cirrhosis of the liver
- •suspected obstructive choledocholithiasis
研究组 & 干预措施
Intervention
chenodeoxycholic acid 1250mg po.
干预措施: chenodeoxycholic acid (Drug)
结局指标
主要结局
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
时间窗: baseline and 3 - 5 months after cholecystectomy
Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)
次要结局
- Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in Lipid Status From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in Stool Pattern Correlated to FGF19(baseline and 3 - 5 months after cholecystectomy)
- Change in Stool Frequency From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy(before cholecystectomy and 3-5 months after cholecystectomy)
- Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy(before and 3-5 months after cholecystectomy)
- Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)
- Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy(baseline and 3 - 5 months after cholecystectomy)