Clinical Trial: Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Study of the Effect of Adjunctive Vivomixx® in Addition to Antibiotics on Systemic and Cerebral Inflammatory Response in Patients With Cirrhosis and Spontaneous Bacterial Pe

Brief Summary:

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.


Detailed Summary:
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Current Primary Outcome: Changes in bacterial translocation (composite measure) [ Time Frame: 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 .


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in systemic inflammatory response and systemic oxidative damage (composite measure) [ Time Frame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge ]

    Systemic Inflammation and immune response will be evaluated by change from baseline in serum C reactive protein (CRP), interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α, IL-10, IL-12, IL-18, IL-22, sTNFR-1, sTNFR-2, sCD163, matrix metalloproteinase (MMP) -9, interferon (IFN)-γ, vascular endothelial growth factor (VEGF), claudin-5, nitrites and nitrates in serum and ascitic fluid.

    Systemic oxidative damage will be evaluated by change from baseline in determination of malondialdehyde (MDA) in blood.

  • Changes in cognitive function (composite measure) [ Time Frame: At baseline at infection resolution (an expected average of 7 days) ]
    Cognitive function will be evaluated by change from baseline in Trail-Making Test A (TMT-A), Trail-Making Test B (TMT-B), and Digit Symbol Test (DST).
  • Changes in brain inflammation (composite measure) [ Time Frame: At baseline (during the first 12-24 hours after inclusion in the study) and after 3 days of treatment. ]

    Brain inflammation will be evaluated by change from baseline in MRI and different biomarkers of neuroinflammation.

    A designed MR protocol will be produced, including imaging using different sequences, and more biochemical (MR spectroscopy) and functional (DTI) studies.



Original Secondary Outcome: Same as current

Information By: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Dates:
Date Received: August 26, 2015
Date Started: September 2016
Date Completion: December 2018
Last Updated: December 14, 2016
Last Verified: December 2016