Effect of pre- and probiotics on liver regeneration after resection – a randomised, double-blind pilot study

Authors: Nada Rayes MD,  Tanja Pilarski, Martin Stockmann MD, Stig Bengmark PhD, Peter Neuhaus PhD, Daniel Seehofer MD.

Published: ?

Method and selection

The study was conducted in vivo, involving human participants.

Design:  Randomized double-blind, placebo controlled, pilot trial.

Treatment: The verum group receiving Synbiotic 2000 and the placebo group receiving the four fibers only. Starting the day before surgery and continuing for 10 days.

Where and when: The study was performed at the Department of General, Visceral and Transplantation Surgery of the University Hospital Charité, Berlin, Germany. Between April 2007 and December 2008.

Sample size: 33 patients.

Sample criteria: Adult patients scheduled for right or extended right hemihepatectomy without bilioenteric anastomosis were eligible for this study. Exclusion criteria were a previous liver transplantation or porto-systemic shunt, chemotherapy within six months prior liver resection, concomitant acute infectious diseases, renal insufficiency and liver fibrosis or cirrhosis.

Analysed material: Body temperature. Measured breath-test and blood sample. Liver function capacity by 13C-Methacetin-breath-test or LiMAx-test, and indocyanine green plasma disappearance rate (ICG-PDR),  laboratory tests (haematology, clinical chemistry including ASAT, ALAT, GLDH, bilirubin, γGT, AP, PCHE, albumin and CRP, INR, factor II and VII), portal vein flow (duplex-sonography), clinical data (ascites).

Results and indicative results

Results

Liver function capacity was comparable in both groups. Complications had a negative impact on liver function. Because complications were more severe in the verum group, a sub-analysis was performed. In case of an uncomplicated course, liver function capacity was better in the patients with synbiotics. No severe side effects occurred (s. 2).

Indicative results

Synbiotics were able to increase liver function capacity in patients after standard hepatectomy.

Results indicate that a mixture of four pre- and probiotics might increase liver function in the early postoperative course following right or extended right hepatectomy. Unfortunately, severe surgical complications more often occurred in the synbiotic group. Probably due to this bias, overall there was no significant improvement in liver function with synbiotics versus placebo (s. 11).

Further research

The study was planned as a pilot study. Therefore, patient numbers are too small and the type of complications too diverse to analyse all subgroups separately. Further studies with more patients are needed to confirm these results. In this case, synbiotics could be very useful especially in patients with extended hepatectomies. (s. 13).

Full research study