Cirrhosis With Spontaneous Bacterial PeritonitisPhase 4NCT07686861
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
A Phase 4 study testing Bifidobacterium quadruple live tablets in people with Cirrhosis With Spontaneous Bacterial Peritonitis, run by Peking University First Hospital at 30 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis With Spontaneous Bacterial Peritonitis
- What is being tested?
- Bifidobacterium quadruple live tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 30 sitesChina
- Study dates
- 31 Jul 2026to 28 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80, any gender
- Meets the diagnostic criteria of the Cirrhosis Ascites Diagnosis and Treatment Guidelines (2023 edition), confirmed cirrhosis ascites SBP
- At least one week before enrollment, no antibiotics or probiotics treatment
- The patient has some organ function and is expected to live more than a year. Platelets ≥50×10⁹/L, hemoglobin ≥90 g/L (patients with anemia need appropriate treatment) ALT和AST<3×ULN Serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL/min
- Voluntarily sign the informed consent form
Who cannot join
- Patients with severe liver damage (total bilirubin levels more than 5 times the upper limit of normal, mainly with elevated direct bilirubin), hepatorenal syndrome, or hepatic encephalopathy
- Patients with combined blood and other site (like lungs or urinary system) infections, or those with significant hemodynamic changes, or severe SBP infections
- Patients with both intrahepatic and extrahepatic malignant tumors, or those with a history of malignant solid tumors or blood cancers
- Patients with gastrointestinal bleeding or intestinal obstruction who need emergency treatment
- People who have had serious cardiovascular disease in the past 6 months or currently（ Researchers consider clinically significant myocardial ischemia, myocardial infarction, or unstable angina.Severe arrhythmias that researchers consider clinically significant.Heart failure at NYHA class III-IV.Other acute serious complications that are life-threatening）
- People with poorly controlled high blood pressure (defined as having a systolic pressure over 160mmHg or a diastolic pressure over 100mmHg despite treatment)
Show all 18Show fewer
- Poorly controlled diabetes (defined as blood sugar over 16.8 mmol/L during the screening period despite treatment) or hypoglycemia (blood sugar below 2.8 mmol/L during screening)
- Select patients who have had esophageal or gastric variceal bleeding within the past 6 months, or those whom the investigator deems at risk of bleeding (if an endoscopy was done within the past 6 months, the results should be collected).
- People with a history of immune deficiencies, including being HIV positive, having other acquired or congenital immune deficiencies, having idiopathic IgA deficiency, or who have taken systemic steroids (≥10 mg/day of prednisone equivalent) or immunosuppressive drugs within 14 days before the trial or are expected to need them during the trial.
- Diagnosed with chronic obstructive pulmonary disease (COPD) and meets the GOLD 2026 Group E criteria
- Patients who are currently receiving antiviral treatment for hepatitis C virus (HCV) or have received it within 12 months before screening. Patients whose antiviral treatment for hepatitis B virus (HBV) has been less than 12 months before screening.
- Autoimmune hepatitis patients who received corticosteroid treatment in the past 6 months
- People who underwent transjugular intrahepatic portosystemic shunt (TIPS) in the past 6 months
- Patients with liver cirrhosis who have non-bacterial peritonitis caused by reasons other than SBP
- Patients who are allergic to probiotic ingredients or can't take medicine orally
- Patients with psychological or mental disorders who are unable to provide an accurate medical history or cooperate
- Pregnant or breastfeeding women
- Other researchers think these patients are not suitable
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Beijing You'an Hospital,Capital Medical University
Beijing
Huiguo Ding
Peking University First Hospital
Beijing
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Shuqiang Wang
West China Hospital of Sichuan University
Chengdu, Sichuan
Hong Tang
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Yongguo Li
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Jinjun Chen
Fuyang People's Hospital
Fuyang, Anhui
Baogui Wang
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian
Haibing Gao
Guangzhou Eighth PeoPle's Hospital,Guangzhou medical University
Guangzhou, Guangdong
Yujuan Guan
Guigang City People's Hospital
Guigang, Guangxi
Riying Lv
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Jie Yang
The First Affiliated Hospital , Zhejiang University School of Medicine
Hangzhou, Zhejiang
Xiaowei Xu
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Ling Zhu
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Yingmei Tang
The First Hospital of Lanzhou University
Lanzhou, Gansu
Liting Zhang
The Second Hospital of Nanjing
Nanjing, Jiangsu
Wei Ye
Ningbo No.2 Hospital
Ningbo, Zhejiang
Liyun Fu
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang
Lanman Xu
The Third Hospital Of Qinhuangdao
Qinhuangdao, Hebei
Liang Miao
Shanghai Public Health Clinical Center
Shanghai
Yinzhong Shen
The Sixth People's Hospital Of Shenyang
Shenyang, Liaoning
Xiaofeng Wu
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Guoxin Hu
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Qingxian Cai
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Liaoyun Zhang
Shanxi Bethune Hospital
Taiyuan, Shanxi
Yan Wang
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Xiulan Xue
Xiamen Hospital of T.C.M.
Xiamen, Fujian
Hong Cai
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
Shuangsuo Dang
Yantai Affiliated Hospital of Shandong Medical and Pharmaceutical University
Yantai, Shandong
Lei Zhang
Yantai Qishan Hospital
Yantai, Shandong
Dalu Song
About this study
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
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.
- Being tested
- Bifidobacterium quadruple live tablets, Bifidobacterium quadruple live bacteria tablets placebo
- Keywords
- Bifidobacterium quadruple live tablets, Cirrhosis with spontaneous bacterial peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium quadruple live tabletsDrug
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 placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Bifidobacterium quadruple live tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Bifidobacterium quadruple live bacteria tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Bacterial Peritonitis(SBP) recurrence rate
Measured: Within 6 months of treatment
Secondary outcomes (17)
SBP recurrence rate
Measured: 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
Measured: Study within one year
SBP infection control rate (assessing overall effectiveness, remarkable effectiveness, effectiveness, and ineffectiveness).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: After 2 weeks and 24 weeks of treatment
Changes in Child-Pugh score from baseline
Measured: 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).
Measured: Within 24 and 48 weeks of treatment
Incidence of diarrhea
Measured: 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.
Measured: Within 24 weeks of treatment
16s RNA sequencing and metabolomics changes compared to baseline
Collect stool samples for 16sRNA sequencing and metabolomics
Measured: At 2 weeks and 24 weeks of treatment
Changes in NRS-2002 score from baseline
Measured: 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.
Measured: 2 weeks of treatment, 24 weeks of treatment, 24 weeks of open phase
mortality rate
Measured: 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.
Measured: Within 24 weeks of treatment, within 24 weeks of the open phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis With Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiqiang Wang, Peking University First Hospital
- Investigators
- Guiqiang Wang, Ph.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686861
- Sponsor's protocol ID
- SLK-SBP-001
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07686861
- Acronym / sponsor ID
- SLK-SBP-001
- Keywords
- Bifidobacterium quadruple live tablets, Cirrhosis with spontaneous bacterial peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Bifidobacterium quadruple live tablets |
| Placebo | Placebo comparator | Drug: Bifidobacterium quadruple live bacteria tablets placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80, any gender
- Meets the diagnostic criteria of the Cirrhosis Ascites Diagnosis and Treatment Guidelines (2023 edition), confirmed cirrhosis ascites SBP
- At least one week before enrollment, no antibiotics or probiotics treatment
- The patient has some organ function and is expected to live more than a year. Platelets ≥50×10⁹/L, hemoglobin ≥90 g/L (patients with anemia need appropriate treatment) ALT和AST<3×ULN Serum creatinine ≤1.5×ULN and creatinine clearance ≥50 mL/min
- Voluntarily sign the informed consent form
Key exclusion criteria (18 listed)
- Patients with severe liver damage (total bilirubin levels more than 5 times the upper limit of normal, mainly with elevated direct bilirubin), hepatorenal syndrome, or hepatic encephalopathy
- Patients with combined blood and other site (like lungs or urinary system) infections, or those with significant hemodynamic changes, or severe SBP infections
- Patients with both intrahepatic and extrahepatic malignant tumors, or those with a history of malignant solid tumors or blood cancers
- Patients with gastrointestinal bleeding or intestinal obstruction who need emergency treatment
- People who have had serious cardiovascular disease in the past 6 months or currently（ Researchers consider clinically significant myocardial ischemia, myocardial infarction, or unstable angina.Severe arrhythmias that researchers consider clinically significant.Heart failure at NYHA class III-IV.Other acute serious complications that are life-threatening）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium quadruple live tabletsTake 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 | Treatment |
| Bifidobacterium quadruple live bacteria tablets placeboTake 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). | Drug | Placebo |
Primary outcome
Spontaneous Bacterial Peritonitis(SBP) recurrence rate
Time frame: Within 6 months of treatment
17 secondary outcomes
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
Time frame: After 2 weeks and 24 weeks of treatment
Changes in gut barrier function compared to baseline
Time frame: After 2 weeks and 24 weeks of treatment
Changes in immunological test indicators from baseline
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
Time frame: Within 24 weeks of treatment
16s RNA sequencing and metabolomics changes compared to baseline
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
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
Time frame: Within 24 weeks of treatment, within 24 weeks of the open phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guiqiang Wang, Ph.D principal investigator
Peking University First Hospital
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bifidobacterium quadruple live tablets in people with Cirrhosis With Spontaneous Bacterial Peritonitis, run by Peking University First Hospital at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guiqiang Wang (13911405123, john131212@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Bacterial Peritonitis(SBP) recurrence rate (time frame: Within 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.