Transplant Trial Watch

Effects of continuous use of probiotics before liver transplantation: A randomized, double-blind, placebo-controlled trial.

Grat M, Wronka KM, et al.

Clinical Nutrition 2017; 04: 04.


Aims
To evaluate the effects of the continuous administration of probiotics before liver transplantation (LT) on pre- and post-transplant patient outcomes.

Interventions
Participants were randomized to receive prior to breakfast up until LT, either probiotic capsules containing 3x109 colony-forming units of Lactococcus lactis PB411 (50.0%), Lactobacillus casei PB121 (25.0%), Lactobacillus acidophilus PB111 (12.5%), and Bifidobacterium bifidum PB211 (12.5%), versus placebo.

Participants
55 adult liver cirrhosis patients aged ≥18 years on the waiting list for LT.

Outcomes
Primary outcomes measured were all-cause, 90-day posttransplant mortality and 30-day posttransplant infection rate. Secondary outcomes measured were serum aspartate and alanine aminotransferase activities, serum bilirubin concentration, and international normalized ratio over the 5 posttransplant days, as well as primary graft non-function, waiting list mortality, pre-transplant infections, MELD score and Child-Turcotte-Pugh class changes, pre transplant hospital admission rate due to complications of liver cirrhosis and infections, fecal microbiota changes and early allograft dysfunction.

Follow-up
90 days

CET Conclusions
This is an interesting double-blind RCT testing pre-transplant probiotic capsules in the prevention of post-operative infection. There was a considerable and significant reduction in 30-day infection rates compared to placebo (5% versus 35%). Five patients stopped taking their assigned capsules and were excluded and not presented. In a study as small as this, these few patients may just be enough to erode the apparent difference in outcome so it is a shame their outcomes are not presented. There was also a significant improvement in post-transplant transaminases, but no difference in 90-day mortality. In conclusion, the improvement in post-transplant infection rate is consistent with other studies and should be taken seriously.

Jadad score
5

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT01735591

Funding source
Non-industry funded