CHU Saint Pierre
Brussels, 1000, Belgium
Location status: Recruiting
Location contact
Jennifer Aoun, Medical doctor
CONTACT
Jennifer Aoun, Medical doctor
PRINCIPAL_INVESTIGATOR
Vinciane Muls, Medical doctor
CONTACT
NCT Number: NCT06814600
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Brussels, 1000, Belgium
Location status: Recruiting
Jennifer Aoun, Medical doctor
CONTACT
Jennifer Aoun, Medical doctor
PRINCIPAL_INVESTIGATOR
Vinciane Muls, Medical doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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)
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire Saint Pierre
Other
Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients: A Prospective Monocentric Study
Acronym: PONI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT04442334
Adenocarcinoma, Body Weight
Antwerp, Belgium
View Trial DetailsNCT05479721
Digestive System Diseases, Disease
San Antonio, Texas, United States
View Trial DetailsNCT06599918
Body Weight, Digestive System Diseases
Barcelona, Spain
View Trial DetailsNCT05147090
Blood-Borne Infections, Chronic Disease
Hong Kong, Hong Kong, China
View Trial Details