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NCT00831337 Clinical Trial

Evaluation of Probiotics in the Treatment of Portal Hypertension

Liver Cirrhosis Clinical Trial

Official title:
The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00831337
Other study ID # PAM 12/06/PB
Secondary ID
Status Completed
Phase N/A
First received January 27, 2009
Last updated November 21, 2016
Start date April 2007
Est. completion date February 2011

Study information
Verified date November 2016
Source Pomeranian Medical University Szczecin
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Description:

Studied probiotics: VSL3

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date February 2011
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• VSL3
2 times daily 450 billion live bacteria (in each saschet)

Locations
Country Name City State
Poland Department of Gastroenterology, Pomeranian Medical University Szczecin

Sponsors (1)
Lead Sponsor Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Laboratory data 28 days Yes
Secondary Clinical and laboratory data 1 months Yes
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