NCT07686861尚未招募4 期
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
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 30
- 主要终点
- Spontaneous Bacterial Peritonitis(SBP) recurrence rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
Spontaneous Bacterial Peritonitis(SBP) recurrence rate
时间窗: Within 6 months of treatment
次要结局
- Incidence of diarrhea(Within 24 weeks of treatment)
- 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)
- 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(After 2 weeks and 24 weeks of treatment)
- Changes in gut barrier function compared to baseline(After 2 weeks and 24 weeks of treatment)
- Changes in immunological test indicators from baseline(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)
- Antibiotic usage(Within 24 weeks of treatment)
- 16s RNA sequencing and metabolomics changes compared to baseline(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(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(Within 24 weeks of treatment, within 24 weeks of the open phase)
研究者
Guiqiang Wang
Chief physician
Peking University First Hospital
研究点 (30)
Loading locations...
相似试验
尚未招募
4 期
Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic DiseasesNCT07275580University of Sao Paulo General Hospital352
尚未招募
3 期
Comparison of Root canal cleaning solutions used in milk teeth of children.CTRI/2026/01/102638Khushi Parmar160
尚未招募
2/3 期
A clinical and antimicrobial study to evaluate the effect of Kush Moola Churna and Nyagrodh Twak Kashaya in the management of Shweta Pradara w.s.r. to LeucorrheaCTRI/2025/05/086893R G G P G Ayurvedic College and Hospital20
招募中
不适用
To assess the effectiveness of different antibiotics in lung and blood infections caused by carbapenem resistant bacteriaCTRI/2024/02/062846Dr Deepak Govil3,000
招募中
4 期
Multicenter clinical trial on the effectiveness and safety of outpatient treatment of acute uncomplicated diverticulitis without antibiotics versus antibiotic treatment. ADIANA Trial.2025-523121-17-00Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia282