The Effect of Probiotics (VSL) on Portal Hypertension

U

University of Alberta

Status and phase

Completed
Phase 2
Phase 1

Conditions

Portal Hypertension

Treatments

Drug: Probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT01032941
VSL3PHTNUoA

Details and patient eligibility

About

The investigators will address the hypothesis that portal hypertension is mediated in part by bacterial or endotoxin translocation and the production of inflammatory mediators (tumor necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and improving systemic and splanchnic hemodynamics.

Full description

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hypertension (VIP study) to determine whether this agent would have beneficial effects in portal pressure reduction (unpublished data Tandon, P. et al.).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).

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

18 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Patients in this group will be given placebo 2 packets BID for 8 weeks.
Treatment:
Drug: Probiotic
VSL#3
Experimental group
Description:
Patients in this group will be given 2 packets of VSL#3 BID for 8 weeks.
Treatment:
Drug: Probiotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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