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

NCT05754996 | Completed Phase 3

• 1 other identifier: CL (3202)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study designed to evaluate the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy

Conditions

Hepatic Encephalopathy

Keywords

Clinical Hepatic Encephalopathy Staging Scale; Hepatic encephalopathy; Nifuroxazide

Outcome Measures

Primary Outcomes (3)

• Number of patients achieving complete reversal of hepatic encephalopathy

  Complete reversal is defined as the reversibility of HE from grade 2 or 3 to grade 0 or 1 according to West Haven criteria

  7 days

• The time for complete reversal of HE

  7 days

• Evaluating the efficacy of nifuroxazide in improving mental status by calculating CHESS score

  Evaluating the efficacy by measuring serum ammonia at baseline and at end of treatment and calculating (CHESS) score at baseline and at end of treatment.

  7 days

Secondary Outcomes (3)

• Length of hospital stay

  7 days

• the rate of adverse events occurring during the treatment

  Maximum 7 days

• Number of patients transferred to ICU

  7 days

Study Arms (2)

lactulose plus Rifaximin plus nifuroxazide

EXPERIMENTAL

Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day. Rifaximin: 550 mg twice daily

Drug: Nifuroxazide; Drug: Lactulose; Drug: Rifaximin 550Mg Tab

Lactulose plus Rifaximin

ACTIVE COMPARATOR

Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day. Rifaximin: 550 mg twice daily

Drug: Lactulose; Drug: Rifaximin 550Mg Tab

Interventions

Nifuroxazide DRUG

Nifuroxazide dosing : 200 mg capsule four times daily

lactulose plus Rifaximin plus nifuroxazide

Lactulose DRUG

Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools

Lactulose plus Rifaximin; lactulose plus Rifaximin plus nifuroxazide

Rifaximin 550Mg Tab DRUG

Rifaximin 550 MG twice daily

Lactulose plus Rifaximin; lactulose plus Rifaximin plus nifuroxazide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

nifuroxazide; Lactulose; Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Mennat Allah S. Emam

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Model Details: This is a pilot, open-label, randomized controlled trial. The recruited patients will be randomly allocated in one of two groups: Group I (The study group): patients will receive oral nifuroxazide: 800 mg daily in 4 divided doses for maximum 7 days and lactulose 30 to 60 mL peroral (PO) three times daily (TID) according to bowel movement (to produce 2 to 3 semisoft stools per day) plus rifaximin 550 mg twice daily. Group II (The control group): patients will receive the standard treatment : lactulose 30 to 60 mL PO TID according to bowel movement (to produce 2 to 3 semisoft stools per day) plus rifaximin 550 mg twice daily..

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: March 12, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

EG (1)