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A Randomized Controlled Trial on the Beneficial Effects of Probiotics on Portal Hemodynamics in Decompensated Cirrhotic Patients

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Portal Hypertension

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Trial Information

A Randomized Controlled Trial on the Beneficial Effects of Probiotics on Portal Hemodynamics in Decompensated Cirrhotic Patients

We have recently completed an open-label uncontrolled trial of the probiotic VSL#3 in 8
patients with compensated cirrhosis and evidence of portal hypertension (VIP study) to
determine whether this agent would have beneficial effects in portal pressure reduction
(unpublished data Tandon, P. et al.). The open label design and the inclusion of
compensated (Child Pugh A) cirrhotic patients in this initial study were chosen to confirm
the safety and tolerance of VSL#3 and the safety of the portal pressure measurements at our
center. No changes of physical status occured. There was a non-significant reduction in
portal pressure from 19.7 to 18.1 mm Hg after 2 months of VSL#3 supplementation.
Furthermore, there was a significant reduction in the serum aldosterone level (p=0.03).
IL-8 levels were reduced in 4/6 patients analyzed to date. These results suggest that VSL#3
results in cytokine reduction and an improvement in the effective circulating volume even in
these well-compensated cirrhotic patients. The comparison of the rest of the
pro-inflammatory mediators and stool microflora is still being analyzed.

The data in our initial study is very promising. As our patients were compensated
cirrhotics with normal intestinal permeability and only mild baseline perturbations in
hepatic function parameters (INR, bilirubin, albumin) and neurohormonal markers
(aldosterone, renin), it is not surprising that a reduction in portal pressure was not
identified. Consistent with previous studies however, these local results confirm the
safety and tolerance of both VSL#3 as well as portal pressure measurements in cirrhotic
patients (20,24,25).

Inclusion Criteria:

- Age 18-80

- Cirrhosis

- Childs-Pugh Class B/C

Exclusion Criteria:

- Bacterial infection

- Grade 3-4 hepatic encephalopathy

- GI bleeding in the past 2 weeks

- Hepatocellular carcinoma beyond the Milan criteria

- Transjugular intrahepatic portosystemic shunt (TIPS), surgical shunt

- Portal vein thrombosis

- Antibiotics in the past 2 weeks

- Myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months

- Active alcohol or illicit drug use

- Failure to consent to the study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Outcome Measure:

Reduction in portal pressure

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Puneeta Tandon, MD, FRCPC, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta


Canada: Health Canada

Study ID:




Start Date:

December 2009

Completion Date:

June 2011

Related Keywords:

  • Portal Hypertension
  • Portal Hypertension
  • Portal Pressure Measurement
  • VSL3
  • Cirrhosis
  • End Stage Liver Disease
  • Probiotics
  • Hypertension
  • Hypertension, Portal