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(unpublished data Tandon, P. et al.).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).