Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sherief Abd-Elsalam
• Collaborator: Tanta University
• Treatments: Lactulose; Nitazoxanide

Criteria

Inclusion Criteria:

Age 18-70 years

Cirrhosis, defined by a combination of any of the following:

• Laboratory findings

• Endoscopic results

• Ultrasound

• Histology Overt hepatic encephalopathy

Exclusion Criteria:

• • Creatinine>1.5 mg/dl

• Alcohol use within prior 4 weeks

• Non-hepatic metabolic encephalopathy

• Hepatocellular carcinoma

• Degenerative CNS disease

• Any significant psychiatric illness or other medical comorbidity