Overview

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Withdrawn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:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Treatments:
Silicon
Criteria
Inclusion Criteria:

- 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 .

Exclusion Criteria:

- 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.