The Effects of Nitazoxanide in Hepatic Encephalopathy

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02334163

Collaborator

Al-Azhar University (Other)

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Nitazoxanide Drug: Oral lactulose Drug: Metronidazole Drug: Rifaximine	Phase 2

Detailed Description

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 severity of Hepatic Encephalopathy using Clinical Hepatic Encephalopathy Staging Scale (CHESS)

C- Monitoring tolerability up to 30 days after the last dose D- Assessment of quality of life using Chronic Liver Disease Questionnaire (CLDQ)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2015

Anticipated Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nitazoxanide group 12 patients will receive the following for 7 days: Oral lactulose 500 mg nitazoxanide tablets twice daily	Drug: Nitazoxanide 500 mg nitazoxanide tablets twice daily Drug: Oral lactulose Oral lactulose (65%)
Active Comparator: Metronidazole group 12 patients will receive the following for 7 days: Oral lactulose 250 mg metronidazole tablets every 8 hours	Drug: Oral lactulose Oral lactulose (65%) Drug: Metronidazole 250 mg metronidazole tablets every 8 hours
Active Comparator: Rifaximine group 12 patients will receive the following for 7 days: Oral lactulose Two 200 mg rifaximine tablets every 8 hours	Drug: Oral lactulose Oral lactulose (65%) Drug: Rifaximine Two 200 mg rifaximine tablets every 8 hours

Arm

Intervention/Treatment

Experimental: Nitazoxanide group

12 patients will receive the following for 7 days: Oral lactulose 500 mg nitazoxanide tablets twice daily

Drug: Nitazoxanide

500 mg nitazoxanide tablets twice daily

Drug: Oral lactulose

Oral lactulose (65%)

Active Comparator: Metronidazole group

12 patients will receive the following for 7 days: Oral lactulose 250 mg metronidazole tablets every 8 hours

Drug: Oral lactulose

Oral lactulose (65%)

Drug: Metronidazole

250 mg metronidazole tablets every 8 hours

Active Comparator: Rifaximine group

12 patients will receive the following for 7 days: Oral lactulose Two 200 mg rifaximine tablets every 8 hours

Drug: Oral lactulose

Oral lactulose (65%)

Drug: Rifaximine

Two 200 mg rifaximine tablets every 8 hours

Outcome Measures

Primary Outcome Measures

Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score) [7 days]
evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment

Secondary Outcome Measures

Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects) [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) [7 days]
Evaluating the effect on quality of life by calculating CLDQ score at baseline and at end of treatment