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Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Sponsor: Peking University First Hospital
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.
Official title: Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence-a Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-07-31
Completion Date
2028-02-28
Last Updated
2026-07-07
Healthy Volunteers
No
Interventions
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).
Locations (30)
Fuyang People's Hospital
Fuyang, Anhui, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Xiamen Hospital of T.C.M.
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Guigang City People's Hospital
Guigang, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Third Hospital Of Qinhuangdao
Qinhuangdao, Hebei, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
The Sixth People's Hospital Of Shenyang
Shenyang, Liaoning, China
Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University
Yantai, Shandong, China
Yantai Qishan Hospital
Yantai, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital , Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
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