Ulcerative Colitis Permeability

NCT07662902 | Enrolling By Invitation

• 1 other identifier: 2024/1022-7
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis (UC); Steatotic Liver Disease; Intestinal Permeability

Keywords

zonulin; intestinal permeability; ulcerative colitis; steatotic liver; lipopolysaccharide

Outcome Measures

Primary Outcomes (2)

• Correlation Between Serum Zonulin Concentration and Liver Stiffness Measurement (LSM)

  Correlation between serum zonulin concentration (ng/mL), measured by enzyme-linked immunosorbent assay (ELISA), and liver stiffness measurement (kPa), assessed by transient elastography (FibroScan), in patients with ulcerative colitis and metabolic dysfunction-associated steatotic liver disease (MASLD).

  Baseline (single study visit)

• Correlation Between Serum Lipopolysaccharide-Binding Protein (LBP) Concentration and Liver Stiffness Measurement (LSM)

  Correlation between serum lipopolysaccharide-binding protein (LBP) concentration (ng/mL), measured by enzyme-linked immunosorbent assay (ELISA), and liver stiffness measurement (kPa), assessed by transient elastography (FibroScan), in patients with ulcerative colitis and metabolic dysfunction-associated steatotic liver disease (MASLD).

  Baseline (single study visit)

Study Arms (1)

Ulcerative Colitis Patients

Adult patients with ulcerative colitis in clinical remission (partial Mayo score \<2) and biochemical remission (fecal calprotectin \<100 μg/g). Participants will undergo transient elastography (FibroScan) for assessment of liver steatosis and fibrosis using controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). Blood samples will be collected for the determination of serum zonulin and lipopolysaccharide-binding protein (LBP) concentrations. Demographic, anthropometric, inflammatory, and treatment-related data will also be recorded. No therapeutic intervention will be administered as part of the study.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from adult patients with established ulcerative colitis receiving routine follow-up care at a tertiary referral gastroenterology center. Eligible participants will be aged 18-70 years, have a documented diagnosis of ulcerative colitis for at least 6 months, and be in clinical and biochemical remission at the time of enrollment. Patients will undergo transient elastography (FibroScan) for assessment of liver steatosis and fibrosis and will be classified according to the presence or absence of metabolic dysfunction-associated steatotic liver disease (MASLD). Consecutive eligible patients who provide written informed consent will be invited to participate.

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.

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples will be collected from all participants at the study visit and stored for the measurement of intestinal permeability biomarkers, including zonulin and lipopolysaccharide-binding protein (LBP). Residual serum samples will be retained and stored under controlled conditions for potential future analyses of additional non-genetic biomarkers related to intestinal permeability, inflammation, and liver disease, subject to participant consent and applicable ethical approvals.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marko Banić, PhD, MD

  University Hospital Dubrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 23, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)