NCT03059537已完成4 期
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Lars Kristian Munck5 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年3月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- Negative predictive value of stimulated deltaFGF19
研究概览
简要总结
This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.
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
- •Consecutive patients referred for SeHCAT
排除标准
- •Treatment with sequestrants within one week before the SeHCAT.
- •Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks.
- •Pregnancy, screening by pregnancy test before inclusion.
- •Breastfeeding women.
- •Small bowel resection, including right sided hemicolectomy.
- •Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks.
- •Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127)
- •Chronic or acute cholecystitis.
- •Liver cirrhosis,
- •Obstructed bile flow causing jaundice or elevated p-bilirubin (> 1,5 UNL).
- •Known disability in gall bladder contractility.
- •Bile duct atresia.
- •Frequent gallstone attacks (>2/month).
研究组 & 干预措施
Stimulation Test
Experimental
Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation
干预措施: Oral chenodeoxycholic acid stimulation (Drug)
结局指标
主要结局
Negative predictive value of stimulated deltaFGF19
时间窗: Individual data are collected within one week
For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT \< 10 %
次要结局
- Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10%(Individual data are collected within one week)
- Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5%(Individual data are collected within one week)
- Correlation of FGF19 to clinical diarrhoea(Individual data are collected within one week)
- 7alpha-CHO by SeHCAT stratum(Individual data are collected within one week)
- Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5%(Individual data are collected within one week)
- Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10%(Individual data are collected within one week)
- FGF19 by SeHCAT stratum(Individual data are collected within one week)
- Correlation of 7alpha-CHO to clinical diarrhoea(Individual data are collected within one week)
研究者
Lars Kristian Munck
DMSci
Zealand University Hospital
研究点 (5)
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