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Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464124
Enrollment
120
Registered
2015-06-08
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy, Hepatic

Brief 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.

Detailed description

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. Hepatic encephalopathy is caused by accumulation of nitrogenous substances, primarily ammonia, in the blood. In advanced stages it is referred to as hepatic coma which may be preceded by seizures. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Lactulose is nonabsorbable disaccharides that are currently used as first line agents for the treatment of HE. Its action is thought to beconversion to lactic acid and acetic acid resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable, and inhibits ammoniagenic coliform bacteria. 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. Mantry and colleagues showed that the number of hospitalizations and the duration of hospital stays were shortened for patients receiving combination therapy compared with those receiving lactulose monotherapy.

Interventions

DRUGNitazoxanide

• Nitazoxanide dosing: 500 mg tablets twice daily

DRUGLactulose

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

Sponsors

Tanta University
CollaboratorOTHER
Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients with total reversal of hepatic encephalopathy6 months

Countries

Egypt

Contacts

Primary ContactSherief Abd-elsalam, lecturer
Sheriefabdelsalam@yahoo.com00201095159522
Backup ContactSherief Abd-elsalam, lecturer
sherif_tropical@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026