NL-OMON35367已完成不适用
(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease
niversitair Medisch Centrum Utrecht0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Colonoscopy clinically indicated to exclude significant disease of the colon or surveillance colonoscopy for Crohn's disease of the colon;
- •2. Informed consent of the patient.
排除标准
- •Patients with Crohn*s disease:
- •1. Harvey-Bradshaw index > 4 or frequency of defaecation > 4 / day
- •2. Serum C-reactive protein >20 (according to the last measurement, measured at most 3 months before the study)
- •3. Surgery of the gastro-intestinal tract (only appendectomy is allowed)
- •4. Previous cholecystectomy
- •5. Gallbladder or bile duct stones
- •6. Previous ERCP with papillotomy.
- •7. Age < 18 years
- •8. Inability to communicate with the patient
- •9. Body Mass Index > 30
- •10. Concomitant primary sclerosing cholangitis or other significant hepatic or biliary pathology
- •11. Any malignancy within 5 years before the study
- •12. Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds or partial thromboplastin time (PTT) > 9 seconds within 3 months before the study
- •13. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics or loperamide/codeine within one month before the study
- •14. Use of drugs, potentially interfering with CDCA (e.g. colestyramine, ursodeoxycholic acid or bile salt questrants), within one month before the study
- •15. Pregnancy or lactation
- •16. Liver function disorders: increased ASAT, ALAT, LDH, gGT and/or AF in relation to the upper limit of normal within 3 months before the study;Disease controls:
- •1. Previous inflammation of the gastrointestinal tract (excluding previous infectious gastroenteritis if>6 months ago)
- •2. Frequency of defaecation > 4 / day
- •3. Serum C-reactive protein >20 (according to the last measurement, measured at most 3 months before the study)
- •4. Surgery of the gastro-intestinal tract (only appendectomy is allowed)
- •5. Previous cholecystectomy
- •6. Gallbladder or bile duct stones
- •7. Previous ERCP with papillotomy.
- •8. Age < 18 years
- •9. Inability to communicate with the patient
- •10. Body Mass Index > 30
- •11. Concomitant primary sclerosing cholangitis, or other significant hepatic or biliary pathology
- •12. Any malignancy within 5 years before the study
- •13. Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds or partial thromboplastin time (PTT) > 9 seconds within 3 months before the study
- •14. Use of steroids, cyclosporine, aTFN compounds, methotrexate, antibiotics or loperamide/codeine within one month before the study
- •15. Use of drugs, potentially interfering with CDCA (e.g. colestyramine, ursodeoxycholic acid or bile salt questrants), within one month before the study
- •16. Pregnancy or lactation
- •17. Liver function disorders: increased ASAT, ALAT, LDH, gGT, AF in relation to the upper limit of normal within 3 months before the study
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