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).
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Fuyang People's Hospital | Fuyang | Anhui | |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian | |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| Xiamen Hospital of T.C.M. | Xiamen | Fujian | |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | |
| Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University | Guangzhou | Guangdong | |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | |
| Shenzhen Third People's Hospital | Shenzhen | Guangdong | |
| Guigang City People's Hospital | Guigang | Guangxi | |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | |
| The Third Hospital Of Qinhuangdao | Qinhuangdao | Hebei | |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | |
| The Sixth People's Hospital Of Shenyang | Shenyang | Liaoning | |
| Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University | Yantai | Shandong | |
| Yantai Qishan Hospital | Yantai | Shandong | |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xian | Shanxi | |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | |
| West China Hospital of Sichuan University | Chengdu | Sichuan | |
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | |
| The First Affiliated Hospital , Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | |
| The Affiliated People's Hospital of Ningbo University | Ningbo | Zhejiang | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07686861 on ClinicalTrials.gov ↗ ← All trials in China