An observational study in NAFLD, Inflammatory Bowel Diseases and Steatosis, sponsored by Centre Hospitalier Universitaire Saint Pierre. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 150 is close to the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
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IBD patients followed at Saint-Pierre University Medical Center, Brussels, Belgium
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: Transient elastometry
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".
Diagnostic Test: Transient elastometry
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.
Prevalence of NAFLD in the population of IBD patients followed at the University Hospital IBD clinic.
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
Behavior of NAFLD according to the IBD activity
Behavior of NAFLD (progression versus regression of steato-fibrosis) according to IBD activity (active disease versus remission)
Time frame: From enrollement to the end of the study, up to 12 months
NAFLD predictors in IBD patients
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.
Time frame: From enrollement to the end of the study, up to 12 months
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Centre Hospitalier Universitaire Saint Pierre