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Clinical Trials/NCT02334163
NCT02334163UnknownPhase 2

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

Ain Shams University1 site in 1 country36 target enrollmentStarted: December 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
36
Locations
1
Primary Endpoint
Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)

Study Overview

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 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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult Patients from 18 to 65 years.
  • Patients with grade II-III Hepatic Encephalopathy.

Exclusion Criteria

  • Patients with active GIT bleeding.
  • Patients with major psychiatric illness.
  • Patients receiving benzodiazepines, narcotics, alcohol and marijuana.
  • Patients with compromised renal or biliary functions.
  • Patients known to have AIDS.
  • Patients receiving medications highly bound to plasma proteins eg. Warfarin.
  • Patients with known hypersensitivity to nitazoxanide.
  • Pregnant or lactating women.

Arms & Interventions

Nitazoxanide group

Experimental

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 500 mg nitazoxanide tablets twice daily

Intervention: Nitazoxanide (Drug)

Nitazoxanide group

Experimental

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 500 mg nitazoxanide tablets twice daily

Intervention: Oral lactulose (Drug)

Metronidazole group

Active Comparator

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 250 mg metronidazole tablets every 8 hours

Intervention: Oral lactulose (Drug)

Metronidazole group

Active Comparator

12 patients will receive the following for 7 days:

  • Oral lactulose
  • 250 mg metronidazole tablets every 8 hours

Intervention: Metronidazole (Drug)

Rifaximine group

Active Comparator

12 patients will receive the following for 7 days:

  • Oral lactulose
  • Two 200 mg rifaximine tablets every 8 hours

Intervention: Oral lactulose (Drug)

Rifaximine group

Active Comparator

12 patients will receive the following for 7 days:

  • Oral lactulose
  • Two 200 mg rifaximine tablets every 8 hours

Intervention: Rifaximine (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)(37 days)
  • Effect of nitazoxanide on patient's quality of life (CLDQ score)(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asmaa Abdel Aziz ElRakaybi

Teaching assistant

Ain Shams University

Study Sites (1)

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