EUCTR2009-013348-35-NL进行中（未招募）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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with Crohn’s disease:
- •Surveillance colonoscopy for established Crohn’s disease of the colon (indicated for clinical reasons)
- •Informed consent of the patient.
- •Disease controls:
- •A clinically indicated colonoscopy to exclude significant disease of the colon
- •Informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with Crohn’s disease:
- •CDAI > 150 or frequency of defaecation > 4 / day
- •Serum C-reactive protein >7
- •Surgery of the gastro-intestinal tract (only appendectomy is allowed)
- •Previous cholecystectomy
- •Gallbladder or bile duct stones
- •Previous ERCP with papillotomy.
- •Age < 18 years
- •Inability to communicate with the patient
- •Body Mass Index > 25
- •Concomitant primary sclerosing cholangitis or other significant hepatic or biliary pathology
- •Any malignancy within 5 years before the study
- •Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds increased compared to control or activated partial thromboplastin time (APTT) > 9 seconds increased compared to control (these values are considered within the normal range)
- •Use of steroids, cyclosporine, methotrexate, anti-TNF compounds, antibiotics, loperamide/codeine or laxatives within one month before the study.
- •Use of drugs, potentially interfering with CDCA (e.g. ursodeoxycholic acid or bile salt sequestrants), within one month before the study
- •Pregnancy or lactation
- •Liver function disorders: ASAT, ALAT, LDH, gGT and/or AF increased above ULN
- •Disease controls:
- •Previous inflammation of the gastrointestinal tract (excluding previous infectious gastroenteritis if>6 months ago)
- •Frequency of defaecation > 4 / day
- •Serum C-reactive protein >7
- •Surgery of the gastro-intestinal tract (only appendectomy is allowed)
- •Previous cholecystectomy
- •Gallbladder or bile duct stones
- •Previous ERCP with papillotomy.
- •Age < 18 years
- •Inability to communicate with the patient
- •Body Mass Index > 25
- •Concomitant primary sclerosing cholangitis, or other significant hepatic or biliary pathology
- •Any malignancy within 5 years before the study
- •Clotting disorders: prolonged prothrombin time (PT) > 2.5 seconds increased compared to control or partial thromboplastin time (PTT) > 9 seconds compared to control (these values are considered normal)
- •Use of steroids, cyclosporine, methotrexate, anti-TNF compounds, antibiotics, loperamide/codeine or laxatives within one month before the study
- •Use of drugs, potentially interfering with CDCA (e.g. ursodeoxycholic acid or bile salt sequestrants), within one month before the study
- •Pregnancy or lactation
- •Liver function disorders: ASAT, ALAT, LDH, gGT, and/or AF increased above ULN
研究者
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(Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease.Crohn's diseasechronic intestinal inflammation10017969NL-OMON35367niversitair Medisch Centrum Utrecht24
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(Patho)Physiological aspects of the bile salt-FXR-FGF19 axis: potential consequences in Crohn's disease.Chronic Intestinal Inflammation10017969Crohn's diseaseNL-OMON33880niversitair Medisch Centrum Utrecht24
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(Patho)Physiological aspects of the bile salt-FXR-FGF19 axis: potential consequences in Crohn’s disease.Crohn's diseaseNL-OMON27642P.D. Siersema, MD, PhD, Utrecht, The Netherlands24
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