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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
360
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).
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).
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
Spontaneous Bacterial Peritonitis(SBP) recurrence rate
Time frame: Within 6 months of treatment
SBP recurrence rate
Time frame: 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
Time frame: Study within one year
SBP infection control rate (assessing overall effectiveness, remarkable effectiveness, effectiveness, and ineffectiveness).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: After 2 weeks and 24 weeks of treatment
Changes in Child-Pugh score from baseline
Time frame: 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).
Time frame: Within 24 and 48 weeks of treatment
Incidence of diarrhea
Time frame: 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.
Time frame: Within 24 weeks of treatment
16s RNA sequencing and metabolomics changes compared to baseline
Collect stool samples for 16sRNA sequencing and metabolomics
Time frame: At 2 weeks and 24 weeks of treatment
Changes in NRS-2002 score from baseline
Time frame: 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.
Time frame: 2 weeks of treatment, 24 weeks of treatment, 24 weeks of open phase
mortality rate
Time frame: 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.
Time frame: Within 24 weeks of treatment, within 24 weeks of the open phase
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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
...and 20 more locations