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Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02464124
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.


Condition or disease Intervention/treatment Phase
Encephalopathy, Hepatic Drug: Nitazoxanide Drug: Lactulose Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Nitazoxanide
• Nitazoxanide dosing: 500 mg tablets twice daily
Other Name: Alenia, Nitclean, Parazoxanide

Drug: Lactulose
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Other Name: Laxolac, Duphlac

Active Comparator: Lactulose alone
Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Drug: Lactulose
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Other Name: Laxolac, Duphlac




Primary Outcome Measures :
  1. Number of patients with total reversal of hepatic encephalopathy [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464124


Contacts
Contact: Sherief Abd-elsalam, lecturer 00201095159522 Sheriefabdelsalam@yahoo.com
Contact: Sherief Abd-elsalam, lecturer 00201095159522 sherif_tropical@yahoo.com

Locations
Egypt
Tanta university - faculty of medicine Recruiting
Tanta, Elgharbia, Egypt
Contact: Sherief Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
Principal Investigator: Asem Elfert, Prof hepatology dept-Tanta
Study Director: Sherief Abd-Elsalam, lecturer hepatology dept-Tanta
Study Chair: Samah Soliman, lecturer hepatology dept-Tanta
Study Chair: Walaa elkhalawany, lecturer hepatology dept-Tanta
Study Chair: Rehab elsheshtawi, lecturer hepatology dept-Tanta
Study Chair: Mennat-Allah Elsawaf, lecturer hepatology dept-Tanta

Responsible Party: Sherief Abd-Elsalam, sponsor investigator, Tanta University
ClinicalTrials.gov Identifier: NCT02464124     History of Changes
Other Study ID Numbers: Hepatic encephalopathy
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Brain Diseases
Brain Diseases, Metabolic
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Metabolic Diseases
Lactulose
Nitazoxanide
Gastrointestinal Agents
Antiparasitic Agents
Anti-Infective Agents