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NOT YET RECRUITING
NCT07686861
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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).

DRUG

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