The Effects of Adding Probiotic, Alone and in Combination With Zinc, to Routine Treatment on Recurrence of Hepatic Encephalopathy, Quality of Life, and Sleep Quality in Patients With Cirrhosis: An Open-Label Randomized Controlled Trial

Overt hepatic encephalopathy (OHE) is a common complication of decompensated cirrhosis. This study aimed to assess the effects of probiotic, alone and in combination with zinc, on OHE recurrence, Model for End-stage Liver Disease (MELD) score, ammonia level, health-related quality of life (HRQoL), and sleep quality in patients with cirrhosis. We performed an open-label randomized controlled trial on patients with decompensated cirrhosis with a previous history of OHE. Eligible patients (n = 45) were divided randomly into three equal groups to receive 30-45 mL lactulose syrup (2-4 times/day), lactulose and probiotic (4.5 x 1011 CFU of bacteria, 2 times/day), or a combination of lactulose, probiotic, and zinc (25 mg) for 3 months. In this study, probiotic, alone or in combination with zinc, had no effect on OHE recurrence, ammonia levels, and MELD score. Mental aspects and total score of HRQoL were improved following probiotic and its combination with zinc, even after adjustment for baseline values, age, and sex. However, physical aspects of HRQoL and sleep quality were only improved by probiotic and zinc combination compared to the lactulose alone. Our findings showed improved HRQoL after treatment with probiotic, alone or in combination with zinc. However, sleep quality was influenced only by probiotic and zinc combination.Trail Registration: This study has been registered in the Iranian registry of clinical trials (IRCT20170609034406N9).