Effect of Vivomixx® on Neuroinflammation in Patients Withs Cirrhosis

NCT03236090 | Withdrawn

• 1 other identifier: IIBSP-VIV-2016-109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis

Conditions

Cirrhosis, Liver

Keywords

Cirrhosis; Probiotics; Systemic inflammation; neuroinflammation; Cognitive function; Bacterial translocation

Outcome Measures

Primary Outcomes (2)

• Change in neuroinflammation

  For substudy 1, neuroinflammation will be measured by MRI at baseline and 30 days

  Change from baseline at 30 days

• Change in neuroinflammation

  For substudy 2, neuroinflammation will be measured by MRI at baseline and 3 days

  Change from baseline at 3 days

Study Arms (2)

Outpatients with refractory ascites

ACTIVE COMPARATOR

20 consecutive outpatients with cirrhosis and refractory ascites Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)

Dietary Supplement: Vivomixx

Patients hospitalized because bacterial infection

ACTIVE COMPARATOR

30 consecutive patients with cirrhosis and bacterial infections. All patients will receive endovenous antibiotics and, only in the case of patients with SBP, also intravenous albumin Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)

Dietary Supplement: Vivomixx

Interventions

Vivomixx DIETARY_SUPPLEMENT

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

Outpatients with refractory ascites; Patients hospitalized because bacterial infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Inflammation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo (we evaluate the probiotic Vivomixx® vs placebo as adjunctive in addition to the standard of care)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Decompensated patients with cirrhosis: 1. Outpatients with refractory ascites (substudy 1) (n=20) 2. Patients hospitalized because bacterial infection (substudy 2) (n=30)

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: August 1, 2017
• Study Start: July 15, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)