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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium quadruple live tablets | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Bacterial Peritonitis(SBP) recurrence rate | Within 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SBP recurrence rate | Within 12 weeks of treatment, within 24 weeks of the open phase | |
| The number of days from controlling SBP infection to the first recurrence of SBP | Study within one year | |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic upgrade rate | Within 2 weeks of hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqiang Wang | Contact | 13911405123 | john131212@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang, Ph.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang People's Hospital | Fuyang | Anhui | China |
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| Bifidobacterium quadruple live bacteria tablets placebo | Drug | 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). |
|
| SBP infection control rate (assessing overall effectiveness, remarkable effectiveness, effectiveness, and ineffectiveness). |
| After 2 weeks of treatment |
| Number of days it takes for each SBP symptom (bloating, abdominal pain, abdominal tenderness, fever) to disappear or return to normal. | During the two-week hospital stay |
| For patients with positive baseline ascitic fluid cultures, the pathogen clearance rate and the proportion of drug-resistant bacteria | 1 week of treatment, 2 weeks of treatment |
| Changes in inflammation markers from baseline | We collected and checked data on IL-6, IL-10, TNF-a, CRP, PCT, white blood cell count, neutrophil count and percentage, and LPS indicators. | After 2 weeks and 24 weeks of treatment |
| Changes in gut barrier function compared to baseline | We collect blood samples to test DAO activity, D-LA, and zonula occludens-1 (zo-1) | After 2 weeks and 24 weeks of treatment |
| Changes in immunological test indicators from baseline | We check and collect data on peripheral blood CD4+, CD8+, the CD4+/CD8+ T cell ratio, and IgA, IgG, IgM levels. | After 2 weeks and 24 weeks of treatment |
| Changes in Child-Pugh score from baseline | 2 weeks of treatment, 24 weeks of treatment, 24 weeks of open phase |
| The occurrence rate of complications of cirrhosis (esophageal and gastric variceal bleeding, primary liver cancer, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis). | Within 24 and 48 weeks of treatment |
| Incidence of diarrhea | Within 24 weeks of treatment |
| Antibiotic usage | Collect information on the types of antibiotics, dosages, frequency, and timing of use from patients using diary cards. | Within 24 weeks of treatment |
| 16s RNA sequencing and metabolomics changes compared to baseline | Collect stool samples for 16sRNA sequencing and metabolomics | At 2 weeks and 24 weeks of treatment |
| Changes in NRS-2002 score from baseline | 2 weeks of treatment, 24 weeks of treatment, 24 weeks of open phase |
| Changes in lab indicators from baseline | We focus on changes in ALB, TB, ALT, AST, PLT, PT, and blood ammonia levels from baseline. | 2 weeks of treatment, 24 weeks of treatment, 24 weeks of open phase |
| mortality rate | Within 2 weeks and 24 weeks of treatment, and within 24 weeks of the open phase |
| Hospital stay | We focus on the time and rate of readmission caused by SBP recurrence. | Within 24 weeks of treatment, within 24 weeks of the open phase |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian | China |
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| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
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| Xiamen Hospital of T.C.M. | Xiamen | Fujian | China |
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| The First Hospital of Lanzhou University | Lanzhou | Gansu | China |
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| Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University | Guangzhou | Guangdong | China |
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| Peking University Shenzhen Hospital | Shenzhen | Guangdong | China |
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| Shenzhen Third People's Hospital | Shenzhen | Guangdong | China |
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| Guigang City People's Hospital | Guigang | Guangxi | China |
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| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
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| The Third Hospital Of Qinhuangdao | Qinhuangdao | Hebei | China |
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| The Second Hospital of Nanjing | Nanjing | Jiangsu | China |
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| The Sixth People's Hospital Of Shenyang | Shenyang | Liaoning | China |
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| Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University | Yantai | Shandong | China |
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| Yantai Qishan Hospital | Yantai | Shandong | China |
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| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
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| Shanxi Bethune Hospital | Taiyuan | Shanxi | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Xian | Shanxi | China |
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| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
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| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
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| The First People's Hospital of Yunnan Province | Kunming | Yunnan | China |
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| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
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| The First Affiliated Hospital , Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| Ningbo No.2 Hospital | Ningbo | Zhejiang | China |
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| The Affiliated People's Hospital of Ningbo University | Ningbo | Zhejiang | China |
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| Beijing You'an Hospital,Capital Medical University | Beijing | China |
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| Peking University First Hospital | Beijing | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
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| Shanghai Public Health Clinical Center | Shanghai | China |
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