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NCT Number: NCT06814600

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Transient elastometry

Diagnostic Test

Controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) will be measured by transient liver elastometry "Fibroscan" to evaluate hepatic steatosis and fibrosis in all patients at baseline. Absence of steatosis S0 is defined as CAP <248 dB/m, mild steatosis S1 with CAP < 268 dB/m, and moderate to severe steatosis ≥ S2 is defined as CAP >280 dB/m. Liver fibrosis will be evaluated using the liver stiffness measurement (LSM) in kPa7.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Behavior of NAFLD according to the IBD activity

    Time frame: From enrollement to the end of the study, up to 12 months

    Behavior of NAFLD (progression versus regression of steato-fibrosis) according to IBD activity (active disease versus remission)

  2. NAFLD predictors in IBD patients

    Time frame: From enrollement to the end of the study, up to 12 months

    Independent predictors (risk factors) for NAFLD in our IBD patients study population such as particular demographics, IBD disease type, IBD disease duration, IBD treatments, patients' immunological profiles, and various inflammatory markers.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Aoun, Medical Doctor

CONTACT

[email protected]

+3225353296

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study title

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

Acronym: PONI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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