Can a parasite drug help fight a deadly gut infection in cirrhosis?

NCT ID NCT07808450

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adding nitazoxanide, a drug used for parasitic infections, to standard antibiotics can improve outcomes for people with liver cirrhosis who develop spontaneous bacterial peritonitis, a severe infection of the abdominal fluid. Researchers will compare two groups: one receiving standard care plus a placebo, and another receiving standard care plus nitazoxanide for 14 days. The main goal is to see if nitazoxanide reduces the number of infection-fighting cells in the abdominal fluid within 48 hours, which would indicate a faster response to treatment.

What this could mean

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

Active substance
Nitazoxanide, an antiparasitic drug with anti-inflammatory effects, added to standard antibiotics
What this could lead to
If it works, adding nitazoxanide to standard antibiotics could reduce the severity of spontaneous bacterial peritonitis and lower the risk of recurrence in people with cirrhosis.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply broadly. Nitazoxanide may not provide added benefit over standard care, and its safety in this setting is not yet established.

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 diagnosed clinically, laboratory-wise, and radiologically. * Presence of ascites. * Diagnosis of spontaneous bacterial peritonitis is defined as an ascitic fluid polymorphonuclear leukocyte count ≥250 cells/mm³, with or without positive culture. * Ability to provide written informed consent. Exclusion Criteria * Secondary bacterial peritonitis. * Recent abdominal surgery. * Hepatocellular carcinoma or other malignancies. * Severe renal impairment (serum creatinine \>2 mg/dL). * Septic shock at presentation. * Pregnancy or lactation. * Known hypersensitivity to Nitazoxanide

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Liver cirrhosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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