NCT07662902Enrolling by invitation
Ulcerative Colitis Permeability
Association Between Zonulin and Lipopolysaccharide-binding Protein as Biomarkers of Intestinal Permeability and Hepatic Steatosis in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- University Hospital Dubrava
- Diseases
- Ulcerative colitis
- NCT number
- NCT07662902
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Dec 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>5 times the upper limit of normal.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Dubrava Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.