Rifaximin's Effect on Covert Hepatic Encephalopathy With SIBO and Gastrointestinal Dysmotility
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Small Intestinal Bacterial Overgrowth (SIBO) is a common and increasingly recognized disorder
in cirrhosis (30% to 73%). One of the most important predisposing factors of SIBO is small
bowel dysmotility. Multiple studies have shown that the presence of SIBO is strongly linked
to the pathogenesis of Minimal Hepatic Encephalopathy (MHE) also known as Covert Hepatic
Encephalopathy (CHE). Consequently, altering and modulating the intestinal microbiota with
ammonia-lowering agents and Rifaximin has been the target treatment strategy in CHE. The aim
of this study is to determine the therapeutic effect of Rifaximin on patients with CHE and
underlying SIBO while assessing the influence of Rifaximin on small bowel motility. In this
prospective interventional study, 40 patients with liver cirrhosis will be screened for
Covert Hepatic Encephalopathy (CHE) using neuro-psychometric tests. Patients diagnosed with
CHE will undergo breath test (BT) for SIBO screening. Afterwards, wireless motility capsule
(The SmartPill) will be performed in all patients with a positive BT. Thereafter, the
cirrhotic patients diagnosed with CHE and SIBO will receive Rifaximin 550 mg PO twice daily
for eight weeks. At the end of treatment, neuro-psychometric tests will be repeated to
evaluate the therapeutic effect on CHE. In addition, BT and SmartPill will be repeated at the
completion of the Rifaximin treatment period to assess the effect on small bowel motility.
All collected clinical parameters at the end of the study will be compared to baseline
values.