Using Nifuroxazide to treat hepatic encephalopathy in patients with liver cirrhosis

Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis

This study is testing if the medication nifuroxazide can help people with liver cirrhosis and moderate to severe brain symptoms feel better by lowering harmful substances in their blood.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT05754996 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the efficacy and safety of nifuroxazide in treating hepatic encephalopathy in patients with liver cirrhosis, specifically those presenting with grade II-III symptoms. The study aims to reduce nitrogenous substances, particularly ammonia, in the blood, which contribute to the neurological dysfunction associated with the condition. Participants will receive nifuroxazide alongside standard treatments like lactulose and rifaximin. The study will assess improvements in cognitive and motor functions as well as overall patient safety.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with liver cirrhosis and confirmed grade II or III hepatic encephalopathy.

Not a fit: Patients with significant psychiatric illnesses, neurological disorders, or renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing hepatic encephalopathy, potentially improving patient outcomes and quality of life.

How similar studies have performed: While the use of nifuroxazide in this context is novel, other studies have shown success with similar approaches in treating hepatic encephalopathy.

Eligibility criteria

Inclusion Criteria:

* Patients suffering from liver cirrhosis aging above 18 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.
* Presence of underlying renal impairment (serum creatinine ≥ 2 mg/dL).
* Alcohol consumption within prior 4 weeks.
* Non-hepatic metabolic encephalopathy.
* Anemia with hemoglobin level \< 7 g/dL.

Where this trial is running

Cairo

• National Hepatology and Tropical Medicine Research Institute (NHTMRI) — Cairo, Egypt (Recruiting)

Study contacts

• Principal investigator: Mennat Allah S. Emam — Cairo University
• Study coordinator: Mennat Allah S. Emam

Conditions Hepatic Encephalopathy; Clinical Hepatic Encephalopathy Staging Scale; Hepatic encephalopathy; Nifuroxazide