NCT03236090

Effect of Vivomixx® on Neuroinflammation in Patients Withs Cirrhosis

Study of the Effect of Vivomixx® on Neuroinflammation Ans Systemic Inflammatory Response in Patients With Cirrhosis

• Status: Withdrawn
• Phase: N/A
• 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 randomized placebo-controlled clinical trial Study Duration: 2 years Study Center: Single center Hospital de la Santa Creu i Sant Pau, Barcelona Objectives: To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis

Detailed description

Study variables Main variables * Neuroinflammation * Systemic inflammatory response Secondary variables * Cognitive function * Bacterial translocation * Intestinal barrier * Systemic oxidative damage * Time until SBP or other bacterial infection resolution in patients with infections * Incidence of complications of cirrhosis and mortality during the study 40 patients, 20 and 30 in each of the two substudies, respectively Diagnosis and Main Inclusion Criteria * Decompensated patients with cirrhosis: 1. Outpatients with refractory ascites (substudy 1) (n=20) 2. Patients hospitalized because bacterial infection (substudy 2) (n=30) Study Product: Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) Duration of administration: 30 days Follow up The following patients' assessments will be performed: in substudy 1 at baseline and at the end of the treatment (30 days), and in substudy 2 at baseline, on day 1, day 2, day 3, day 7, at infection resolution, and at discharge or day 30. Clinical and analytical assessments will be performed every three months after the end of the study Comparator Placebo (we evaluate the probiotic Vivomixx® vs placebo as adjunctive in addition to the standard of care) Statistical Methodology Fisher's exact test for categorical variables and Student's "t" test and Mann-Whitney and Wilcoxon tests for quantitative variables. Correlations will be assessed by Spearman test. A two-sided p value \<0.05 will be considered statistically significant

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vivomixx	Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)

Timeline

• Start date: 2017-07-15
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2017-08-01
• Last updated: 2018-03-13

Locations

1 site across 1 country: Spain