Quercetin as an Adjunct to Primary Sclerosing Cholangitis Therapy with 5-ASA through Inhibition of N-acetylation

IBD Clinical Trials Unit, Mater Research Ltd.0 个研究点目标入组 25 人开始时间: 2019年10月9日最近更新: 2019年10月14日

适应症

试验速览

暂无简介。

•1) Age>18
•2) A diagnosis of UC
•3) Disease in remission (SCCAI < 3 which is accepted as correlating with remission and has been confirmed in prospective validation cohorts, no specific duration of remission mandated)
•4) On 5-ASA therapy, ideally on Mezavant at 4.8 g/day or Pentasa at 4 g/day.

•1) Chronic renal impairment (eGFR< 60)
•2) Significant liver disease defined as PSC or elevated liver function tests > 1.5 x upper limit of normal
•3) Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites, or
•spontaneous hepatic encephalopathy
•4) Findings highly suggestive of liver disease of an alternative or concomitant aetiology, including but
•not limited to chronic alcoholic liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson’s disease, a1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or secondary sclerosing cholangitis
•5) Pregnancy or lactation (due to unknown risk profile of quercetin in pregnancy)
•6) Active illicit drug or alcohol abuse
•7) Need for chronic use of antibiotics
•8) History of cholangiocarcinoma, colon cancer
•9) History of a colectomy with > 1/3 bowel resected
•10) Taking a polyphenol supplement chronically including resveratrol, curcumin, green tea extract,
•11) Taking an immunosuppressant or biologic for IBD
•12) Hypersensitivity to quercetin

发起方

IBD Clinical Trials Unit, Mater Research Ltd.