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Simple blood test may spot hidden liver trouble in colitis patients

NCT ID NCT07662902

Knowledge-focused Sponsor: University Hospital Dubrava Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether two blood markers, zonulin and LBP, can help detect liver damage in people with both ulcerative colitis (UC) and fatty liver disease. Researchers will measure these markers and use a special ultrasound to check liver stiffness in 100 adults with UC who are in remission. The goal is to see if these markers could be used to identify advanced liver problems without needing a biopsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to detect serious liver damage in people with ulcerative colitis and fatty liver disease.
What could go wrong
This is an early observational study with only 100 participants. It only looks for a link, not a treatment, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcoholic fatty liver disease fatty liver disease metabolic dysfunction-associated steatotic liver disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intestinal permeability Steatotic liver disease Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Dubrava

    Zagreb, 10000, Croatia

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Other studies related to the condition(s) this trial covers.