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临床试验/NCT06814600
NCT06814600招募中不适用

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: a Prospective Monocentric Study

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.

研究概览

简要总结

Non-alcoholic Fatty Liver Disease (NAFLD) refers to a spectrum of disease characterized by the presence of more than 5% of steatosis in hepatocytes of individuals who consume little or no alcohol. It ranges from simple steatosis without evidence of inflammation, to the association of steatosis and inflammation with cellular necrosis, the so-called non-alcoholic steatohepatitis (NASH). NAFLD has become increasingly common in developed countries affecting up to 38% of the population. It is mostly but not exclusively associated with metabolic syndrome including obesity, insulin resistance, and hypertension. There is growing evidence of a close interaction between the gut and the liver "Gut-liver axis", particularly in the pathogenesis of NAFLD. The pathophysiological mechanism behind this association is not well understood but involves small intestinal bacterial overgrowth (SIBO), intestinal wall inflammation and increased permeability, all leading to systemic translocation of microbial metabolites including endotoxins and pro-inflammatory markers called Pathogen Associated Molecular Pattern (PAMPs). Thus, the gut-liver interaction, mediated by cytokines and inflammatory proteins seem to be the cornerstone of this complex liver disease.

Recent studies underlined the increased prevalence of NAFLD in the Inflammatory Bowel Disease (IBD) population, accounting for almost 32% of hepatic extra-intestinal manifestations of the disease. Several hypotheses have been proposed to explain the pathophysiology behind this association, encompassing chronic intestinal wall inflammation, increased intestinal permeability and altered gut microbiota or dysbiosis. To our knowledge, no studies have been conducted so far to investigate the correlation between intestinal disease activity (IBD flare versus remission state) and NAFLD incidence and behavior (progression versus regression of steato-fibrosis). We therefore aim to conduct a prospective paired study, on IBD patients followed at Saint-Pierre University Hospital, aiming to explore this correlation.

In this paired study design, patients will be their own controls over the course of their disease: An evaluation of NAFLD will be done for all patients during both phases of their inflammatory bowel disease: In the active phase and in remission phase. Our primary outcome is to assess NAFLD prevalence in the IBD population followed at our institution. Secondary outcomes will be to explore NAFLD prevalence and behavior (progression versus regression of steato-fibrosis) according to IBD activity, IBD type, IBD duration and types of IBD treatments.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Diagnosis of IBD based on clinical, endoscopic, and histological gounds according to the latest ECCO guidelines
  • •Willingness to provide informed consent for study participation

排除标准

  • •Presence of established liver disease (including autoimmune hepatitis, primary biliary cholangitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, positive serology for viral hepatitis B or C)
  • •History of hepatocellular carcinoma or liver transplantation
  • •History of excessive alcohol consumption defined as >3 units per day for women and > 5 units per day for men
  • •Pregnancy at the time of recruitment
  • •Failure to perform an elastography mesure or missing elastography data

结局指标

主要结局

Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.

时间窗: From enrollement to the end of the study, up to 12 months

Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.

次要结局

  • Behavior of NAFLD according to the IBD activity(From enrollement to the end of the study, up to 12 months)
  • NAFLD predictors in IBD patients(From enrollement to the end of the study, up to 12 months)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Aoun

Medical doctor

Centre Hospitalier Universitaire Saint Pierre

研究点 (1)

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