drugset / Trial / NCT07686861

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

NCT07686861 ↗

Phase 4 Not yet recruiting 360 enrolled Peking University First Hospital
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2026-07-31
Primary completion
2027-07-31
Completion
2028-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Bifidobacterium quadruple live tablets Other / unclassified 1.5 g Oral

Indications