The impact of targeting the gut microbiome on improvement in liver function in individuals with Primary Sclerosing Cholangitis: The Queensland Clinical Network Study.

Princess Alexandra Hospital0 个研究点目标入组 34 人开始时间: 2021年6月23日最近更新: 2024年1月15日

适应症

试验速览

暂无简介。

•Male and females (females of childbearing age must have negative pregnancy test within 48 hours of participation and agreement to practice contraception for the duration of the study), age =>14 years old and <75 years,
•0 Established clinical diagnosis of PSC (confirmed by a hepatologist) with or without an associated IBD
•oHistory of chronic cholestatic disease of at least 6 months duration,
•oSerum alkaline phosphatase level at least 1.5 times the upper limit of normal.
•oCholangiography or MRCP demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC (without evidence for other causes of the biliary abnormalities).
•0 Patients have given informed consent for study participation.
•0 All other treatments for PSC and IBD need to be stable for the last 4 weeks prior to inclusion.

•Findings highly suggestive of hepatobiliary disease of other aetiology complicating PSC,
•Anticipated need for liver transplantation in one year (e.g. determined by Mayo model with an estimate of <75% one year survival without transplantation),
•Recurrent variceal bleeding, presence of ascites, or encephalopathy,
•Active drug or alcohol use, pregnancy, breast feeding,
•Serum creatinine over 1.5 fold of the norm,
•Prior history of allergic reactions to antibiotics belonging to the family to be used,
•Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
•Evidence of active malignancy.

发起方