Gut leakiness markers and fatty liver in people with ulcerative colitis
Studies whether zonulin and LBP blood levels relate to liver fat in ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Ulcerative Colitis Permeability
Key facts
- Where
- Zagreb, CroatiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07662902, who can take part
Where in Croatia
- University Hospital DubravaZagreb, CroatiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Dubrava
- Trial code
- NCT07662902
- Record updated
- 25 June 2026
- Original description
Study aim: To investigate whether the values of zonulin and lipopolysaccharide-binding protein (LBP) as biomarkers of intestinal permeability are related to the degree of liver steatosis, steatohepatitis and fibrosis in patients with ulcerative colitis (UC) and metabolic-associated steatotic liver disease (MASLD).Read full original descriptionShow less
Association Between Zonulin and Lipopolysaccharide-binding Protein as Biomarkers of Intestinal Permeability and Hepatic Steatosis in Patients With Ulcerative Colitis
Study aim: To investigate whether the values of zonulin and lipopolysaccharide-binding protein (LBP) as biomarkers of intestinal permeability are related to the degree of liver steatosis, steatohepatitis and fibrosis in patients with ulcerative colitis (UC) and metabolic-associated steatotic liver disease (MASLD).
Subjects and methods: Participants with UC will be included, except for those whose inflammation affects only the rectum. During the clinical and biochemical remission of UC, a physical examination, taking of anamnestic data, blood tests, and abdominal ultrasound with measurement of parameters of liver steatosis, steatohepatitis, and fibrosis (controlled attenuation parameter, FibroScan-AST score, liver stiffness measure) will be performed via transient elastography. Blood samples will be taken to determine zonulin and LBP, and statistical data will be processed.
Expected contribution to the field: Indicate the potential of zonulin and LBP as markers for advanced liver fibrosis in patients with MASLD and UC.
Inclusion: Adults aged 18-70 years; Established diagnosis of ulcerative colitis (UC) for at least 6 months according to current European Crohn's and Colitis Organisation (ECCO) guidelines; Clinical remission of UC defined as a partial Mayo score <2; Biochemical remission of UC defined as fecal calprotectin (FC) <100 μg/g; Ability to undergo transient elastography (FibroScan) with reliable measurements; Written informed consent provided prior to study participation.
Exclusion: Known chronic liver disease of other etiology, including autoimmune, viral, alcoholic, metabolic, or malignant liver disease; Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology; Celiac disease; Type 1 diabetes mellitus; History of malignancy; Hepatic congestion due to heart failure; Portal vein thrombosis; Budd-Chiari syndrome; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >5 times the upper limit of normal; Ulcerative colitis limited to the rectum (ulcerative proctitis) according to the most recent endoscopic assessment; Excessive alcohol consumption (≥140 g/week for women or ≥210 g/week for men); Unreliable transient elastography measurements (CAP or LSM); Decompensated liver cirrhosis; Biliary obstruction with cholestatic liver enzyme abnormalities; Neoplastic liver infiltration; Pregnancy; Inability or unwillingness to provide written informed consent.