Ulcerative Colitis Permeability

Enrolling by invitation

Conditions studied: Ulcerative Colitis (UC), Steatotic Liver Disease, Intestinal Permeability

In brief

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.

Key facts

Study ID

NCT07662902

Run by

University Hospital Dubrava

People needed

100

Starts

2025-12-01

Expected to finish

2027-05-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Known chronic liver disease of other etiology, including autoimmune, viral, alcoholic, metabolic, or malignant liver disease.
• Decompensated liver cirrhosis.
• Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology.
• Celiac disease.
• Type 1 diabetes mellitus.
• History of malignancy.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >5 times the upper limit of normal.
• Hepatic congestion due to heart failure.
• Biliary obstruction with cholestatic liver enzyme abnormalities.
• Neoplastic liver infiltration.
• Portal vein thrombosis.
• Budd-Chiari syndrome.
• Pregnancy.
• Inability or unwillingness to provide written informed consent.

Where it is running

• University Hospital Dubrava — Zagreb, Croatia

Full record on ClinicalTrials.gov

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