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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Between Serum Zonulin Concentration and Liver Stiffness Measurement (LSM)
Timeframe: Baseline (single study visit)
2
Correlation Between Serum Lipopolysaccharide-Binding Protein (LBP) Concentration and Liver Stiffness Measurement (LSM)