TCTR20180509001.

Study name	Comparison between rifaximin vs lactulose for treatment of hepatic encephalopathy.
Methods	Randomised, double‐blind, parallel‐assignment, efficacy, treatment phase 3 trial
Participants	Adults with cirrhosis and hepatic encephalopathy with Conn score ≥ 1. Those with spontaneous bacterial peritonitis or septicaemia were treated with antibiotics before recruitment; and people with gastrointestinal haemorrhage had bleeding controlled. Participants could receive lactulose less than a day before enrolment.
Interventions	Intervention: rifaximin, dose not specified Control intervention: lactulose, dose not specified Duration of treatment: unclear
Outcomes	Primary outcome: improvement of clinical syndrome of hepatic encephalopathy, by Conn score and asterixis grading Secondary outcomes: adverse events, including length of hospital stay and mortality Duration of follow‐up: unknown
Starting date	22 December 2016; currently recruiting
Contact information	Contact for Scientific Queries: Watcharasak Chotiyaputta / Patchara Pannin 022549008 watcharasak.cho@mahidol.ac.th / patchara_p@bio‐nnova.com Bangkok, Thailand 10700
Notes	Target sample size = 80. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3507 www.thaiclinicaltrials.org/TCTR20180509001 Sponsor: Bio‐innova and Synchron Co., Ltd Outcome data from this trial, once completed, could be included in future versions of this review

CT: computerised tomography; MELD: model for end‐stage liver disease; MRI: magnetic resonance imaging; PHES: psychometric hepatic encephalopathy score; TIPS: transjugular intrahepatic portosystemic shunt