Clinical Trial: The Effects of Nitazoxanide in Hepatic Encephalopathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study

Brief Summary: Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of administering nitazoxanide on the improvement of patient's quality of life.

Detailed Summary:

Nitazoxanide (NTZ) is a thiazolide anti-infective with activity against anaerobic bacteria, protozoa and viruses. 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. Based on the excellent safety profile of NTZ, the present pilot study is conducted hopefully to prove the efficacy of nitazoxanide in treating patients experiencing HE grade II-III.

Study design:The study is Prospective, Randomized, Controlled, Open-Label, Pilot study.

Method: The study will include a total of 36 patients with grade II-III Hepatic Encephalopathy, and an informed consent will be obtained from every patient before being included.

All the patients will receive oral lactulose, plus either nitazoxanide, metronidazole or rifaximine.

A- All patients will be subjected to the following at baseline:

  • Patient's full history
  • Liver disease staging using Model for End stage Liver Disease (MELD) score
  • Measurement of serum electrolytes (Na+, K+, Ca2+)

B- All patients will be subjected to the following at baseline and at the end of treatment:

  • Measuring Blood ammonia level
  • Measuring liver function tests (AST, Total bilirubin, international normalized ratio (INR), Serum albumin, prothrombin time (PT)), serum creatinine and complete blood count (CBC)
  • Assessing severi
    Sponsor: Ain Shams University

    Current Primary Outcome: Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score) [ Time Frame: 7 days ]

    evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects) [ Time Frame: 37 days ]
      Evaluating the safety of nitazoxanide by estimation of treatment- related undesirable effects
    • Effect of nitazoxanide on patient's quality of life (CLDQ score) [ Time Frame: 7 days ]
      Evaluating the effect on quality of life by calculating CLDQ score at baseline and at end of treatment


    Original Secondary Outcome: Same as current

    Information By: Ain Shams University

    Dates:
    Date Received: January 6, 2015
    Date Started: December 2014
    Date Completion: April 2015
    Last Updated: January 7, 2015
    Last Verified: January 2015