Status:
WITHDRAWN
Effect of Vivomixx® on Neuroinflammation in Patients Withs Cirrhosis
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Spanish Clinical Research Network - SCReN
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Study variables Main variables * Neuroinflammation * Systemic inflammatory response Secondary variables * Cognitive function * Bacterial translocation * Intestinal barrier * Systemic oxidative damage...
Eligibility Criteria
Inclusion
- Outpatients with cirrhosis and refractory ascites according to current definition (29) (substudy 1), and hospitalized patients with cirrhosis and an episode of bacterial infection (substudy 2) 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 (28). Bacteremia, urinary infections, pneumonia, cellulitis, other bacterial infections and possible or suspected infections will be diagnosed according to current guidelines (13,14,28). All patients with SBP, bacteremia or pneumonia will be included. However patients with urinary infections, cellulitis or suspected infection these non-SBP infections will be required to fulfil the following requirements: at least two criteria of SIRS (systemic inflammatory response syndrome) (Annex I) (30) and CRP (C-reactive protein) \>= 10 mg/dl (28).
Exclusion
- Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy determining a poor short-term prognosis.
- Advanced liver insufficiency \[MELD (model for end-stage liver disease) \>25\].
- Marked symptomatic comorbidities (neurological, cardiac, pulmonary, renal, psychiatric, HIV infection).
- Septic shock, ileus, need for tracheal intubation or intensive care unit.
- Immunomodulatory drugs.
- In substudy 1, any infection at inclusion in the study.
Key Trial Info
Start Date :
July 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03236090
Start Date
July 15 2017
End Date
March 9 2018
Last Update
March 13 2018
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025