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Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:
A Randomized Controlled Trial Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis

Clinical Trial Summary

Evaluating the efficacy and safety of the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy

Clinical Trial Description

Hepatic Encephalopathy (HE) is a central nervous system dysfunction caused by liver insufficiency and/or portosystemic shunting, manifesting as a wide spectrum of neurological or psychiatric abnormalities characterized by alteration of cognitive and motor function. The pathogenesis of hepatic encephalopathy is believed to be due to increased nitrogenous substances, primarily ammonia, in the blood. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status. Treatment options include lactulose administered orally and non-absorbable antibiotics. Lactulose is nonabsorbable disaccharides that is currently used as first line agents for the treatment of HE. Its action is thought to be due to Colonic metabolism of lactulose to lactic acid results in acidification of the gut lumen. This favors conversion of ammonium (NH4) to ammonia (NH3) and the passage of ammonia from tissues into the lumen. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Lactulose also works as a cathartic, reducing colonic bacterial load. Nifuroxazide is an oral broad-spectrum nitrofuran antibiotic that is commonly used as an intestinal anti-infective agent. It is active against the majority of intestinal bacteria: Gram-positive (Staphylococcus family) and Gram-negative (Enterobacteriaceae family: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Yersinia) and is therefore expected to decrease ammonia production and to reverse the symptoms of HE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05754996
Study type Interventional
Source Cairo University
Contact Mennat Allah S. Emam
Phone 01007906781
Email mennatallah.elmlegy@fue.edu.eg
Status Recruiting
Phase Phase 3
Start date March 12, 2023
Completion date December 2024
View Details
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