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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluating the efficacy and safety of the efficacy and safety of nifuroxazide in combination with lactulose in comparison to lactulose alone in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy

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

Details

• Lead Sponsor: Cairo University
• Treatments: Lactulose; Nifuroxazide

Criteria

Inclusion Criteria:

• Patients suffering from liver cirrhosis aging from 18-64 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade II or III) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with Model for End-Stage Liver Disease (MELD) score ≤ 25 and patients are able to swallow.

Exclusion Criteria:

• Patients with neurological or communication problems.

• Degenerative central nervous system (CNS) disease.

• Any significant psychiatric illness.

• Patients with previous intake of nifuroxazide and rifaximin within the last month.

• Anemia with hemoglobin level < 8 g/dL.

• Presence of underlying renal impairment (serum creatinine > 1.5 mg/dL).

• Alcohol consumption within prior 4 weeks.

• Non-hepatic metabolic encephalopathy.