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NCT07686861
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Conditions: Cirrhosis With Spontaneous Bacterial Peritonitis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 360
Sponsor: Peking University First Hospital
Location: Fuyang People's Hospital Fuyang Anhui
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 Criteria
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\
Source: ClinicalTrials.gov (NCT07686861). StuddyBuddy aggregates publicly available trial information.