Clinical trial NCT02552862: Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with cirrhosis hospitalized with an episode of SBP 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 .

Exclusion Criteria:

* Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy.
* Advanced liver insufficiency \[MELD (model for end-stage liver disease) \>25\].
* Active alcohol intake (in the previous 3 months).
* Neurological disease.
* Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, HIV infection).
* Previous antibiotic treatment, including norfloxacin and rifaximin.
* Septic shock, ileus, need for tracheal intubation or intensive care unit.
* Immunomodulatory drugs.

Primary outcomes:
measure: Changes in bacterial translocation (composite measure)
timeFrame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Secondary outcomes:
measure: Changes in systemic inflammatory response and systemic oxidative damage (composite measure)
timeFrame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
measure: Changes in cognitive function (composite measure)
timeFrame: At baseline at infection resolution (an expected average of 7 days)
measure: Changes in brain inflammation (composite measure)
timeFrame: At baseline (during the first 12-24 hours after inclusion in the study) and after 3 days of treatment.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: