Evaluation of Probiotics in the Treatment of Portal Hypertension

Pomeranian Medical University Szczecin

Status: Completed

Conditions: Encephalopathy; Portal Hypertension; Liver Cirrhosis

Treatments: Dietary Supplement: VSL3

Study type: Interventional

Funder types: Other

Identifiers

NCT00831337

PAM 12/06/PB

Details and patient eligibility

About

This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.

Full description

Studied probiotics: VSL3

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
• Confirmed portal hypertension
• 18 years and older
• compliant patients

Exclusion criteria

• Antibiotic treatment in last 3 months
• Lactulose treatment in last 3 months
• Patients taking NSAIDS in lat 3 months
• Steroid treatment in last 3 months
• Ongoing and active infection
• Pregnant woman
• Cancer diagnosis
• decompensated diabetes mellitus
• active or past treatment with recombinant cytokines (e.g. anty TNF, interferon etc)
• medication altering function of CNS, suffering from neurological or ophthalmological conditions
• initiating the therapy with beta blockers within the prior 12 weeks
• mental disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Liver cirrhosis compensated

Experimental group

Description:

VSL3 supplemented twice daily for 28 days

Treatment:

Dietary Supplement: VSL3

Liver cirrhosis decompensated

Experimental group

Description:

VSL3 supplemented twice daily for 28 days

Treatment:

Dietary Supplement: VSL3

Control group

Experimental group

Description:

VSL3 supplemented twice daily for 28 days

Treatment:

Dietary Supplement: VSL3