Effect of probiotics on nutritional status, biochemical parameters, and disease severity in cirrhotic patients referred for liver transplantation-A randomised double blind, placebo-controlled trial.

INTRODUCTION

Probiotics have been shown to be effective in many diseases. However, their effects on the nutritional status in patients with cirrhosis is uncertain.

AIM: We aimed to study the effect of probiotics on nutritional status, biochemical parameters, and liver disease severity in patients with cirrhosis referred for liver transplantation.

METHODS

A randomised, double-blind, placebo-controlled study was conducted from July 2021-October 2022. A total of 215 patients with cirrhosis referred for liver transplantation were enrolled and randomised to two groups to receive either probiotics (VSL#3, Sun Pharma, India, 112.5 billion colony-forming units (cfu) containing eight strains of bacteria) or placebo (corn starch filled capsules), two capsules/day for six weeks. Nutritional assessment was done, and biochemical parameters were measured before and after the intervention.

RESULTS

Nutritional assessment parameters like body mass index (p = 0.001), triceps skin fold thickness (p = 0.011), muscle strength (p = 0.007) and subjective global assessment scores (p < 0.000) showed a positive trend in the probiotic group. Probiotic intake also significantly downregulated direct bilirubin levels (p = 0.043) and increased albumin levels compared to baseline, but other biochemical parameters remained unchanged. Child Turcotte Pugh score also decreased significantly compared to pre therapy (p = 0.0001). These changes were not observed in the placebo group. Moreover, probiotic VSL#3 supplementation was safe and well-tolerable without any adverse events in patients with cirrhosis.

CONCLUSION

Probiotic VSL#3 supplementation improved the nutritional status, reduced the severity of liver disease and was safe and tolerable in patients with cirrhosis.

TRIAL REGISTRATION: www.ctri.nic.in (CTRI/2021/07/034917).