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.
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
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
Parallel
Bifidobacterium quadruple live tablets
DrugTake 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
DrugTake 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).
Spontaneous Bacterial Peritonitis(SBP) recurrence rate
SBP recurrence rate
The number of days from controlling SBP infection to the first recurrence of SBP
SBP infection control rate (assessing overall effectiveness, remarkable effectiveness, effectiveness, and ineffectiveness).
Number of days it takes for each SBP symptom (bloating, abdominal pain, abdominal tenderness, fever) to disappear or return to normal.
Antibiotic upgrade rate
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