Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akik gyulladásos bélbetegséggel (IBD) élnek, és egy kórházban kezelik őket. A vizsgálat a zsírmájbetegséget nézi a betegség aktív és nyugvó szakaszában is.

Életkor

18 éves vagy idősebb

Nem

Mindkét nem csatlakozhat

A betegség stádiuma

Gyulladásos bélbetegség (IBD), amelyet klinikai, endoszkópos és szövettani leletek alapján állapítottak meg a legújabb ECCO-irányelvek szerint

A részvétel fő kizáró okai

• Már ismert májbetegség, például autoimmun hepatitis, primer biliáris cholangitis, hemochromatosis, Wilson-kór vagy pozitív hepatitis B vagy C szerológia
• Korábbi hepatocellularis carcinoma vagy májátültetés
• Korábbi túlzott alkoholfogyasztás: nőknél napi 3 egységnél több, férfiaknál napi 5 egységnél több
• Terhesség a bevonás idején
• Sikertelen elasztográfiás mérés vagy hiányzó elasztográfiás adat

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Baseline assessment

  All patients with a confirmed diagnosis of IBD (cf. inclusion criteria) will have their demographic and clinical data collected during consultation via the medical record system Xcare/Abrumet. This include their age, gender, ethnicity, calculated BMI, alcohol consumption, smoking history, medical history (Hypertension, diabetes type II and dyslipidemia) and surgical history. Clinical data such as disease type, duration and IBD related current medications will be noted. The gastroenterologist will fill an assessment questionnaire in order to clinically assess the disease activity. This consists of Partial Mayo clinical score (pMayo) for Ulcerative Colitis and Harvey Bradshaw Index (HBI) for Crohn's disease. Remission is defined as a pMayo ≤ 1 or a HBI \<5, mild disease is defined as pMayo between 2 and 4, or HBI between 5 and 7. Finally, moderate to severe disease is defined as pMayo ≥ 5, or HBI \> 85. According to the data provided, patients will be classified into two sub-groups accor

  Kezelés: Transient elastometry

• Follow-up Assessment

  Patients selected in the phase A of the study will be followed over time, through the course of their disease following the usual protocol for IBD patients follow up. They will undergo the same assessment when a change in the baseline intestinal disease activity occurs: This is defined as a progression from remission state to active disease state or vice versa. The assessment consists of the clinical questionnaire to be filled by the gastroenterologist during a follow up consultation (pMayo and HBI), routine blood tests for biochemical follow up of the disease activity, measurements of cytokines and inflammatory proteins (similar to phase A), FIB-4 score calculation and a repeat transient elastometry "Fibroscan".

  Kezelés: Transient elastometry