Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC

niversitair Medisch Centrum Utrecht0 个研究点目标入组 45 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Clinical activity index <= 4
•Long-standing extensive or left-sided* ulcerative colitis for more than 8 years
•Age 18-65 years
•Using 6-mercaptopurine or azathioprine to maintain remission
•For women only: sufficient anti-conception
•Signed informed consent
•* added referring to updated guidelines for CRC screening in UC patients (Cairns et al., Gut 2010;59:666-89) and data demonstrating association between inflammation and risk of neoplasia.

•- Dysplasia or colorectal cancer before study entry
•- Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection)
•- Colectomy
•- Family history of colorectal cancer
•- Symptomatic cholelithiasis
•- Cholecystitis
•- Coagulation disorder or use anticoagulants that can not be temporarily discontinued, precluding the taking of biopsies
•- Chronic renal impairment/failure
•- Diabetes mellitus (higher risk for developing renal disease)
•- Hypertension (higher risk for developing renal disease)
•- Allergy to 5-ASA or UDCA
•- Vertricular/gastric or duodenal ulcera
•- For women only: Pregnancy, lactation or childbearing potential without adequate contraception
•- Galactose-intolerance, Lapp lactasedeficience or glucose-galactose malabsorption
•- Treatment with antacids containing hydroxide, hypolipidemics, high-dose calcium supplements (>= 1200 mg/day), or any other medication disturbing the enterohepatic circulation
•- Treatment with methotrexate, riphampicine, lactulose or glucocorticosteroids.
•- Unwillingness to be informed about accidental diagnostic findings

发起方

niversitair Medisch Centrum Utrecht