Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
Status:
Withdrawn
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau