Study of the Effect of Vivomixx® on Neuroinflammation Ans Systemic Inflammatory Response in Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in neuroinflammation
研究概览
简要总结
Study Design:
Double-blind randomized placebo-controlled clinical trial
Study Duration:
2 years
Study Center:
Single center Hospital de la Santa Creu i Sant Pau, Barcelona
Objectives:
To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis
详细描述
Study variables Main variables
- Neuroinflammation
- Systemic inflammatory response Secondary variables
- Cognitive function
- Bacterial translocation
- Intestinal barrier
- Systemic oxidative damage
- Time until SBP or other bacterial infection resolution in patients with infections
- Incidence of complications of cirrhosis and mortality during the study 40 patients, 20 and 30 in each of the two substudies, respectively Diagnosis and Main Inclusion Criteria
- Decompensated patients with cirrhosis:
- Outpatients with refractory ascites (substudy 1) (n=20)
- Patients hospitalized because bacterial infection (substudy 2) (n=30)
Study Product:
Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
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
- Single (Participant)
盲法说明
Placebo (we evaluate the probiotic Vivomixx® vs placebo as adjunctive in addition to the standard of care)
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
- •Outpatients with cirrhosis and refractory ascites according to current definition (29) (substudy 1), and hospitalized patients with cirrhosis and an episode of bacterial infection (substudy 2) 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 (28). Bacteremia, urinary infections, pneumonia, cellulitis, other bacterial infections and possible or suspected infections will be diagnosed according to current guidelines (13,14,28). All patients with SBP, bacteremia or pneumonia will be included. However patients with urinary infections, cellulitis or suspected infection these non-SBP infections will be required to fulfil the following requirements: at least two criteria of SIRS (systemic inflammatory response syndrome) (Annex I) (30) and CRP (C-reactive protein) >= 10 mg/dl (28).
排除标准
- •Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy determining a poor short-term prognosis.
- •Advanced liver insufficiency [MELD (model for end-stage liver disease) >25].
- •Marked symptomatic comorbidities (neurological, cardiac, pulmonary, renal, psychiatric, HIV infection).
- •Septic shock, ileus, need for tracheal intubation or intensive care unit.
- •Immunomodulatory drugs.
- •In substudy 1, any infection at inclusion in the study.
研究组 & 干预措施
Outpatients with refractory ascites
20 consecutive outpatients with cirrhosis and refractory ascites Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
干预措施: Vivomixx (Dietary Supplement)
Patients hospitalized because bacterial infection
30 consecutive patients with cirrhosis and bacterial infections. All patients will receive endovenous antibiotics and, only in the case of patients with SBP, also intravenous albumin Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
干预措施: Vivomixx (Dietary Supplement)
结局指标
主要结局
Change in neuroinflammation
时间窗: Change from baseline at 3 days
For substudy 2, neuroinflammation will be measured by MRI at baseline and 3 days
Change in neuroinflammation
时间窗: Change from baseline at 30 days
For substudy 1, neuroinflammation will be measured by MRI at baseline and 30 days
次要结局
未报告次要终点