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Could a simple nutritional plan boost survival after liver procedure?

NCT ID NCT06814626

Disease control Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial investigates whether a 12-week nutritional intervention, including a personalized diet and a supplement called Friliver, can improve six-month survival in people with liver cirrhosis who have muscle loss (sarcopenia) and fluid buildup (refractory ascites). Participants receive the intervention after a procedure called TIPS, which helps manage fluid buildup. The study compares survival rates between those who get the nutritional support and those who do not.

What this could mean

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

Active substance
a dietary supplement called Friliver (amino acids and nutrients) plus a personalized diet
What this could lead to
If successful, this nutritional approach could improve survival and muscle health in people with advanced liver disease undergoing TIPS.
What could go wrong
This is a small, early-phase trial with only 72 participants, so results may not apply to all patients. The supplement may not be effective or could cause digestive side effects.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 72 people

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

Started

Oct 2022

Expected to finish

Dec 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.

Ages

18 to 80 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: * men and women with an age ≥ 18 and ≤ 80 years * clinical, radiological or histological diagnosis of liver cirrhosis * diagnosis of RA * confirmation of sarcopenia defined in CT scan as the sum of the psoas muscle areas measured at the level of the 3rd lumbar vertebra (PMA) ≤16 cm2 * informed consent signed Exclusion Criteria: * severe hepatic insufficiency (bilirubin\> 5 mg/dl, MELD score\> 18, Child-Pugh score\> 9) * Congestive heart failure class ≥2 according to New York Heart Association criteria (NYHA) * Active coronary heart disease (myocardial infarction within 6 months of the study) * Severe pulmonary hypertension suspected on echocardiogram (systolic pulmonary arterial pressure \[PAPs\]\> 35 mmHg) and confirmed with right cardiac catheterization (PAPs\> 45mmHg) * Chronic renal failure (creatinine\> 3 mg/dl) * Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG) * History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months * Uncontrolled systemic sepsis * Presence of Hepatocellular carcinoma * Complete portal vein thrombosis * Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy) * Diagnosis of extra hepatic neoplasia * Transplant recipients * Patients unable or unwilling to comply with the protocol requirements * Pregnant or lactating women * Patients unable to autonomously express their consent (incapable patients) * any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study

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Conditions

The condition(s) this trial relates to.

Ascites cirrhosis of liver Sarcopenia

As listed by the trial registrant

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

Liver cirrhosis Refractory ascites in patients with cirrhosis Sarcopenia in liver cirrhosis

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione

    RECRUITING

    Palermo, 90127, Italy

  • University Clinic for Visceral Surgery and Medicine, Inselspital

    RECRUITING

    Bern, 3010, Switzerland

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