Can an antioxidant boost the Body's fight against a deadly infection in cirrhosis?

NCT ID NCT07803952

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This trial tests whether adding N-acetylcysteine (NAC), an antioxidant, to standard care improves early response in people with liver cirrhosis who develop spontaneous bacterial peritonitis (SBP), a serious infection of the abdominal fluid. Researchers will give 60 adults either NAC or a placebo twice daily for 7 days alongside usual antibiotics and albumin. They will measure changes in infection markers in the abdominal fluid after 48 hours and track organ function and short-term outcomes.

What this could mean

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

Active substance
N-acetylcysteine (NAC) given as an add-on to standard therapy
What this could lead to
If it works, adding NAC to standard care could reduce treatment failure, organ damage, and early death in people with cirrhosis and spontaneous bacterial peritonitis.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply broadly. NAC may not improve outcomes and could cause side effects like nausea or allergic reactions.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 65 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: Adult patients (≥18 years) with liver cirrhosis, confirmed by clinical, radiological, or histopathological findings, who are newly diagnosed with SBP based on an ascitic fluid polymorphonuclear (PMN) leukocyte count ≥250 cells/mm³ according to the American Association for the Study of Liver Diseases (AASLD) criteria (2). Eligible participants were required to have undergone diagnostic paracentesis for ascitic fluid analysis and to provide informed consent prior to enrollment. Exclusion Criteria * Secondary bacterial or fungal peritonitis. * Recent abdominal surgery or requiring immediate surgical intervention. * Known hypersensitivity to NAC. * Pregnancy or lactation. * Septic shock, established HRS-AKI requiring rescue therapy, or renal replacement therapy at enrollment. * Advanced malignancy or terminal illness. * Previous NAC administration during the current SBP episode. * Inability to receive oral study medication. * Participation in another interventional trial that may affect study outcomes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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