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Fontan Patients' hidden gut troubles revealed in new study

NCT ID NCT06731322

Knowledge-focused Sponsor: University Medical Centre Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 52 adults who had Fontan surgery for heart defects, comparing them to healthy people. Researchers checked for gut damage, inflammation, and nutrition problems using blood tests and body scans. The goal was to understand how the surgery affects the gut and overall health, even without obvious symptoms.

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

52 people

The number who actually took part.

Started

Oct 2024

Finished

Oct 2025

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

We will invite adult patients who have undergone Fontan surgery and are followed up in the Adult Congenital Heart Disease Clinic at the Clinical Department of Cardiology, University Medical Centre Ljubljana. Patients with a known protein-losing enteropathy following Fontan surgery will be excluded. The control group will consist of healthy adults without known chronic disease or regular medications or adult patients after surgical or percutaneous repair of simple congenital heart defects (atrial or ventricular septal defects). Control patients will be without clinical signs of heart failure and with normal systemic venous pressure as assessed by ultrasound.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adult patients (\>18 years old) after Fontan operation Exclusion Criteria: * Active protein losing enteropathy * Disability preventing informed consent

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Conditions

The condition(s) this trial relates to.

Inflammation

As listed by the trial registrant

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

Fontan circulation Fontan procedure

Contacts and locations

Locations

  • University medical centre Ljubljana (UKC Ljubljana)

    Ljubljana, 1000, Slovenia

More trials for these conditions

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