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

Abstract

Probiotics have been shown to be effective in many diseases. However, their effects on the nutritional status in patients with cirrhosis is uncertain. 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. 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. 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. Probiotic VSL#3 supplementation improved the nutritional status, reduced the severity of liver disease and was safe and tolerable in patients with cirrhosis. www.ctri.nic.in (CTRI/2021/07/034917).