Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
NCT ID: NCT02464124
Last Updated: 2017-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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lactulose plus nitazoxanide
* Nitazoxanide dosing: 500 mg tablets twice daily
* Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Nitazoxanide
• Nitazoxanide dosing: 500 mg tablets twice daily
Lactulose
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Lactulose alone
Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Lactulose
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Interventions
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Nitazoxanide
• Nitazoxanide dosing: 500 mg tablets twice daily
Lactulose
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Cirrhosis, defined by a combination of any of the following:
* Laboratory findings
* Endoscopic results
* Ultrasound
* Histology Overt hepatic encephalopathy
Exclusion Criteria
* Alcohol use within prior 4 weeks
* Non-hepatic metabolic encephalopathy
* Hepatocellular carcinoma
* Degenerative CNS disease
* Any significant psychiatric illness or other medical comorbidity
18 Years
70 Years
ALL
No
Sponsors
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Tanta University
OTHER
Sherief Abd-Elsalam
OTHER
Responsible Party
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Sherief Abd-Elsalam
sponsor investigator
Principal Investigators
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Asem Elfert, Prof
Role: PRINCIPAL_INVESTIGATOR
hepatology dept-Tanta
Sherief Abd-Elsalam, lecturer
Role: STUDY_DIRECTOR
hepatology dept-Tanta
Samah Soliman, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Walaa elkhalawany, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Rehab elsheshtawi, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Mennat-Allah Elsawaf, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Locations
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Tanta university - faculty of medicine
Tanta, Elgharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hepatic encephalopathy
Identifier Type: -
Identifier Source: org_study_id
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