跳至主要内容
临床试验/NCT02464020
NCT02464020已完成1 期

A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis

University of Minnesota1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Fecal bile acid composition

研究概览

简要总结

The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. The investigators will also assess the blood and stool of healthy people, and people with IBD (without PSC) as a control group.

详细描述

Primary Sclerosing Cholangitis (PSC) is a chronic inflammatory and fibrotic disease of the intra and extrahepatic ducts of unknown etiology that predominately occurs in people with Inflammatory Bowel Disease (IBD). One hypothesis is that altered microbiome (bacteria in the gut) in people with IBD are responsible for the inflammation in the liver seen in PSC. Bile acids (BAs) represent a unique mechanism of communication between the host and intestinal microbiome and the liver. Synthesized in the liver, bile acids are metabolized by intestinal bacteria hydroxylases to secondary BAs which then re-enter the portal circulation. Altered metabolism of BAs has been associated with gallstones and colorectal cancer and is hypothesized to play a role in the inflammatory response of certain disease such as IBD and PSC.

IBD has been associated with impairment of bile acid (BA) metabolism. In addition BAs play a role in regulating bacterial growth of the intestine and thus have an effect on the integrity of the intestinal mucosa, which is an essential component of IBD. Perturbations in this system could increase bacterial translocation into the portal system due to loss of protective mucosal factors or bacterial overgrowth.

The overall goal of this study is to assess the changes in BAs metabolism following administration of oral vancomycin. The investigators will also describe the relationship of the intestinal microbiome and BA metabolism in PSC/IBD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented diagnosis of PSC made by typical clinical, radiographic and biochemical criteria.
  • Diagnosis of PSC > 3 months

排除标准

  • Antibiotic use within 30 days of initial study visit
  • Probiotic use within 30 days of initial study visit
  • Extensive ileal disease
  • Severe of fulminant IBD
  • Diabetes and/or metabolic syndrome
  • Chronic disease state deemed unacceptable for the study per investigator review
  • Decompensated Cirrhosis
  • Females who are pregnant or breastfeeding

研究组 & 干预措施

primary sclerosing cholangitis

Experimental

Two week course of oral vancomycin 500mg twice a day.

干预措施: Vancomycin (Drug)

结局指标

主要结局

Fecal bile acid composition

时间窗: 5 days

Fecal samples will be collected over 1 week. Bile acids will be measured on each sample and the average composition of primary to secondary bile acids over the 5 day period will be assessed. Comparison will be made pre and post vancomycin

次要结局

  • Microbiome diversity analysis(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验