Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence

NCT07686861 | Not Yet Recruiting Phase 4

• 1 other identifier: SLK-SBP-001
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 30

Brief Summary

This is a prospective, randomized, double-blind, placebo-controlled multicenter clinical study targeting cirrhosis patients with Spontaneous Bacterial Peritonitis(SBP), aiming to evaluate whether adding Bifidobacterium quadruple probiotics can improve infection control rates and reduce SBP recurrence. Meanwhile, by extending the follow-up period into a real-world clinical observation phase, the study will assess whether Bifidobacterium quadruple probiotics can lower SBP recurrence and extend the lifespan of cirrhosis patients. The primary endpoint of the study is the recurrence rate of SBP during the double-blind treatment period. The study plans to enroll 360 patients.

Conditions

Cirrhosis With Spontaneous Bacterial Peritonitis

Keywords

Bifidobacterium quadruple live tablets; Cirrhosis with spontaneous bacterial peritonitis

Outcome Measures

Primary Outcomes (1)

• Spontaneous Bacterial Peritonitis(SBP) recurrence rate

  Within 6 months of treatment

Secondary Outcomes (17)

• SBP recurrence rate

  Within 12 weeks of treatment, within 24 weeks of the open phase

• The number of days from controlling SBP infection to the first recurrence of SBP

  Study within one year

• SBP infection control rate (assessing overall effectiveness, remarkable effectiveness, effectiveness, and ineffectiveness).

  After 2 weeks of treatment

• Number of days it takes for each SBP symptom (bloating, abdominal pain, abdominal tenderness, fever) to disappear or return to normal.

  During the two-week hospital stay

• For patients with positive baseline ascitic fluid cultures, the pathogen clearance rate and the proportion of drug-resistant bacteria

  1 week of treatment, 2 weeks of treatment

Other Outcomes (1)

• Antibiotic upgrade rate

  Within 2 weeks of hospitalization

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: Bifidobacterium quadruple live tablets

Placebo

PLACEBO COMPARATOR

Drug: Bifidobacterium quadruple live bacteria tablets placebo

Interventions

Bifidobacterium quadruple live tablets DRUG

Take Bifidobacterium quadruple live tablets orally at 4.5 g per dose, which is 9 tablets at a time, once after breakfast, continuously for 2 weeks. After 2 weeks, continue taking Bifidobacterium quadruple live tablets, but switch to 1.5 g per dose, which is 3 tablets per time, three times a day, after meals, and continue until 24 weeks are completed.After the treatment, there's a 24-week open phase where participants can voluntarily take the tablets (1.5g three times a day).

Treatment

Bifidobacterium quadruple live bacteria tablets placebo DRUG

Take 4.5 g of Bifidobacterium quadruple live bacteria tablets placebo orally each time, which is 9 tablets at once, after breakfast in the morning, for 2 weeks. After 2 weeks, continue taking the Bifidobacterium quadruple live bacteria tablets placebo, but change to 1.5 g each time, which is 3 tablets, 3 times a day, taken after meals, until the end of 24 weeks.After the treatment, there's a 24-week open phase where participants can voluntarily take the tablets (1.5g three times a day).

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (30)

Fuyang People's Hospital

Fuyang, Anhui, China

Location

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Xiamen Hospital of T.C.M.

Xiamen, Fujian, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Location

Guigang City People's Hospital

Guigang, Guangxi, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

The Third Hospital Of Qinhuangdao

Qinhuangdao, Hebei, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Location

The Sixth People's Hospital Of Shenyang

Shenyang, Liaoning, China

Location

Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University

Yantai, Shandong, China

Location

Yantai Qishan Hospital

Yantai, Shandong, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The First Affiliated Hospital , Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

Location

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

Beijing You'an Hospital,Capital Medical University

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Shanghai Public Health Clinical Center

Shanghai, China

Location

Study Officials

• Guiqiang Wang, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guiqiang Wang

CONTACT

13911405123; john131212@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 7, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)