Study of the Effect of Adjunctive Vivomixx® in Addition to Antibiotics on Systemic and Cerebral Inflammatory Response in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Changes in bacterial translocation (composite measure)
研究概览
简要总结
Study Design: Double-blind placebo-controlled clinical trial
Study Duration:2 years
Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)
Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in patients with cirrhosis and SBP
Number of Subjects: 30
Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau
Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15)
Duration of administration: During hospitalization due to SBP episode
Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could decrease bacterial translocation and systemic and cerebral proinflammatory state. This would result in a faster SBP resolution, a decrease in the incidence of complications and an improvement in cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau.
- •Cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy. SBP will be diagnosed by an ascitic fluid neutrophil count > 250/mm3 with or without positive culture .
排除标准
- •Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy.
- •Advanced liver insufficiency [MELD (model for end-stage liver disease) >25].
- •Active alcohol intake (in the previous 3 months).
- •Neurological disease.
- •Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, HIV infection).
- •Previous antibiotic treatment, including norfloxacin and rifaximin.
- •Septic shock, ileus, need for tracheal intubation or intensive care unit.
- •Immunomodulatory drugs.
研究组 & 干预措施
Vivomixx®
Vivomixx® is a probiotic mixture of 8 proprietary strains. Thirty consecutive patients with cirrhosis and SBP will be randomized to receive Vivomixx® , sachets containing 450 x 109 bacteria, 2 every 12 hours during all the hospitalization until a maximum of 30 days (n=15), or placebo (n=15).
All patients will receive endovenous antibiotics and also intravenous albumin 1.5 g/kg weight the first day and 1 g/kg weight the third day of treatment. The management of patients will follow current guidelines.
干预措施: Vivomixx® (Drug)
Placebo
Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in bacterial translocation (composite measure)
时间窗: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Bacterial translocation will be evaluated by change from baseline in bacterial DNA in blood and ascitic fluid, lipopolysaccharide binding protein (LBP), intestinal fatty acid-binding protein (I-FABP) and intestinal bile acid binding protein (I-BABP) in blood, and polyethylene glycols (PEG) and claudin 3 in urine .
次要结局
- Changes in brain inflammation (composite measure)(At baseline (during the first 12-24 hours after inclusion in the study) and after 3 days of treatment.)
- Changes in systemic inflammatory response and systemic oxidative damage (composite measure)(At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge)
- Changes in cognitive function (composite measure)(At baseline at infection resolution (an expected average of 7 days))