drugset / Trial / NCT02464124

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

NCT02464124

Phase 2/3 Unknown 120 enrolled Tanta University Tanta University · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.

Timeline

Start
2016-01
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitazoxanide Other / unclassified 500 mg Oral
Background Lactulose Other / unclassified 30 ml Oral
Background Lactulose Other / unclassified 60 ml Oral