NCT02552862

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

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spontaneous Bacterial Peritonitis

Interventions

Type	Name	Description
DRUG	Vivomixx®	Vivomixx® is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) and lactobacilli (L. paracasei DSM 24733, L. acidophilus DSM 24735, L. delbrueckii subsp bulgaricus DSM 24734, L. plantarum DSM 24730). The active agent will be supplied as a 4.4g sachet at a dose of 450 billion live bacteria per sachet with maltose and silicon dioxide as excipients.
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2015-09-17
• Last updated: 2016-12-15

Locations

1 site across 1 country: Spain