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Could probiotics stop a deadly infection from coming back in liver disease?

NCT ID NCT07686861

Disease control Sponsor: Peking University First Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether adding a probiotic (Bifidobacterium quadruple live tablets) to standard antibiotics can better control and prevent the return of spontaneous bacterial peritonitis (SBP) in people with cirrhosis. SBP is a serious infection of the abdominal fluid that often recurs. The trial enrolls 360 adults with cirrhosis and SBP, giving them either the probiotic or a placebo alongside antibiotics for 24 weeks, then following them for another 24 weeks to see if the probiotic reduces recurrence and extends survival.

What this could mean

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

Active substance
Bifidobacterium quadruple live tablets
What this could lead to
If it works, this could point toward a simple probiotic supplement to prevent dangerous abdominal infections in people with cirrhosis, potentially reducing hospitalizations and improving survival.
What could go wrong
This is a Phase 4 trial, but probiotics may not outperform placebo in preventing recurrence. Results may not apply to all cirrhosis patients, and long-term safety data are limited.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 360 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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: * Age 18-80, any gender * Meets the diagnostic criteria of the Cirrhosis Ascites Diagnosis and Treatment Guidelines (2023 edition), confirmed cirrhosis ascites SBP * At least one week before enrollment, no antibiotics or probiotics treatment * The patient has some organ function and is expected to live more than a year. Platelets ≥50×10⁹/L, hemoglobin ≥90 g/L (patients with anemia need appropriate treatment) ALT和AST\<3×ULN Serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL/min * Voluntarily sign the informed consent form Exclusion Criteria: * Patients with severe liver damage (total bilirubin levels more than 5 times the upper limit of normal, mainly with elevated direct bilirubin), hepatorenal syndrome, or hepatic encephalopathy * Patients with combined blood and other site (like lungs or urinary system) infections, or those with significant hemodynamic changes, or severe SBP infections * Patients with both intrahepatic and extrahepatic malignant tumors, or those with a history of malignant solid tumors or blood cancers * Patients with gastrointestinal bleeding or intestinal obstruction who need emergency treatment * People who have had serious cardiovascular disease in the past 6 months or currently（ Researchers consider clinically significant myocardial ischemia, myocardial infarction, or unstable angina.Severe arrhythmias that researchers consider clinically significant.Heart failure at NYHA class III-IV.Other acute serious complications that are life-threatening） * People with poorly controlled high blood pressure (defined as having a systolic pressure over 160mmHg or a diastolic pressure over 100mmHg despite treatment) * Poorly controlled diabetes (defined as blood sugar over 16.8 mmol/L during the screening period despite treatment) or hypoglycemia (blood sugar below 2.8 mmol/L during screening) * Select patients who have had esophageal or gastric variceal bleeding within the past 6 months, or those whom the investigator deems at risk of bleeding (if an endoscopy was done within the past 6 months, the results should be collected). * People with a history of immune deficiencies, including being HIV positive, having other acquired or congenital immune deficiencies, having idiopathic IgA deficiency, or who have taken systemic steroids (≥10 mg/day of prednisone equivalent) or immunosuppressive drugs within 14 days before the trial or are expected to need them during the trial. * Diagnosed with chronic obstructive pulmonary disease (COPD) and meets the GOLD 2026 Group E criteria * Patients who are currently receiving antiviral treatment for hepatitis C virus (HCV) or have received it within 12 months before screening. Patients whose antiviral treatment for hepatitis B virus (HBV) has been less than 12 months before screening. * Autoimmune hepatitis patients who received corticosteroid treatment in the past 6 months * People who underwent transjugular intrahepatic portosystemic shunt (TIPS) in the past 6 months * Patients with liver cirrhosis who have non-bacterial peritonitis caused by reasons other than SBP * Patients who are allergic to probiotic ingredients or can't take medicine orally * Patients with psychological or mental disorders who are unable to provide an accurate medical history or cooperate * Pregnant or breastfeeding women * Other researchers think these patients are not suitable

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver infectious peritonitis prevention target

As listed by the trial registrant

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

Cirrhosis with spontaneous bacterial peritonitis

How to take part

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

  1. The places running it

    30 sites. 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

  • Beijing You'an Hospital,Capital Medical University

    Beijing, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Fuyang People's Hospital

    Fuyang, Anhui, China

  • Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University

    Guangzhou, Guangdong, China

  • Guigang City People's Hospital

    Guigang, Guangxi, China

  • Mengchao Hepatobiliary Hospital Of Fujian Medical University

    Fuzhou, Fujian, China

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang, China

  • Peking University First Hospital

    Beijing, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Shanghai Public Health Clinical Center

    Shanghai, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, China

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, China

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital , Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, China

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi, China

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, China

  • The Sixth People's Hospital Of Shenyang

    Shenyang, Liaoning, China

  • The Third Hospital Of Qinhuangdao

    Qinhuangdao, Hebei, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Xiamen Hospital of T.C.M.

    Xiamen, Fujian, China

  • Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University

    Yantai, Shandong, China

  • Yantai Qishan Hospital

    Yantai, Shandong, China