Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02552862
Study type Interventional
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact
Status Withdrawn
Phase Phase 3
Start date September 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Completed NCT02528097 - A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis N/A
Completed NCT01193426 - Diagnostic of Spontaneous Bacterial Peritonitis
Completed NCT00359853 - Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis Phase 4
Active, not recruiting NCT04159870 - Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis Phase 3
Completed NCT04153604 - Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
Completed NCT06234046 - Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin Phase 3
Recruiting NCT01598870 - Diagnosis of Spontaneous Bacterial Peritonitis N/A
Recruiting NCT00761098 - Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP) Phase 4
Completed NCT05401721 - Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Completed NCT02468089 - To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT04746937 - Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis Phase 3
Recruiting NCT02759497 - Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis N/A
Completed NCT02608658 - Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites N/A
Completed NCT02388035 - Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis N/A
Completed NCT03163745 - Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis
Completed NCT04273373 - Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis. N/A
Active, not recruiting NCT04395365 - Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis Phase 3
Terminated NCT00570960 - Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Phase 4
Recruiting NCT05422118 - Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis N/A