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Clinical Trials in China / NCT07686861
Starting soon Phase 4

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

NCT07686861 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Phase 4
Started
2026-07-31
Last updated
2026-07-07

Condition(s) studied

Cirrhosis With Spontaneous Bacterial Peritonitis

Investigational drug(s) / intervention(s)

Bifidobacterium quadruple live tabletsBifidobacterium quadruple live bacteria tablets placebo

Bifidobacterium quadruple live tablets: 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).

Bifidobacterium quadruple live bacteria tablets placebo: 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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Fuyang People's Hospital Fuyang Anhui
Mengchao Hepatobiliary Hospital Of Fujian Medical University Fuzhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Xiamen Hospital of T.C.M. Xiamen Fujian
The First Hospital of Lanzhou University Lanzhou Gansu
Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University Guangzhou Guangdong
Peking University Shenzhen Hospital Shenzhen Guangdong
Shenzhen Third People's Hospital Shenzhen Guangdong
Guigang City People's Hospital Guigang Guangxi
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
The Third Hospital Of Qinhuangdao Qinhuangdao Hebei
The Second Hospital of Nanjing Nanjing Jiangsu
The Sixth People's Hospital Of Shenyang Shenyang Liaoning
Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University Yantai Shandong
Yantai Qishan Hospital Yantai Shandong
First Hospital of Shanxi Medical University Taiyuan Shanxi
Shanxi Bethune Hospital Taiyuan Shanxi
The Second Affiliated Hospital of Xi'an Jiaotong University Xian Shanxi
Sichuan Provincial People's Hospital Chengdu Sichuan
West China Hospital of Sichuan University Chengdu Sichuan
The First People's Hospital of Yunnan Province Kunming Yunnan
The Second Affiliated Hospital of Kunming Medical University Kunming Yunnan
The First Affiliated Hospital , Zhejiang University School of Medicine Hangzhou Zhejiang
Ningbo No.2 Hospital Ningbo Zhejiang
The Affiliated People's Hospital of Ningbo University Ningbo Zhejiang
Beijing You'an Hospital,Capital Medical University Beijing China
Peking University First Hospital Beijing China
The First Affiliated Hospital of Chongqing Medical University Chongqing China
The Second Affiliated Hospital of Chongqing Medical University Chongqing China
Shanghai Public Health Clinical Center Shanghai China

More Peking University First Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07686861 on ClinicalTrials.gov ↗ ← All trials in China