MedTrace Logo

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

NCT02464124 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-08-21

No results posted yet for this study

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.

Conditions

  • Encephalopathy, Hepatic

Interventions

DRUG

Nitazoxanide

• Nitazoxanide dosing: 500 mg tablets twice daily

DRUG

Lactulose

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

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Asem Elfert, Prof · hepatology dept-Tanta

  • Sherief Abd-Elsalam, lecturer · hepatology dept-Tanta

  • Samah Soliman, lecturer · hepatology dept-Tanta

  • Walaa elkhalawany, lecturer · hepatology dept-Tanta

  • Rehab elsheshtawi, lecturer · hepatology dept-Tanta

  • Mennat-Allah Elsawaf, lecturer · hepatology dept-Tanta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464124 on ClinicalTrials.gov