The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Ain Shams University
- 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
12 patients will receive the following for 7 days:
- Oral lactulose
- 500 mg nitazoxanide tablets twice daily
Intervention: Nitazoxanide (Drug)
Nitazoxanide group
12 patients will receive the following for 7 days:
- Oral lactulose
- 500 mg nitazoxanide tablets twice daily
Intervention: Oral lactulose (Drug)
Metronidazole group
12 patients will receive the following for 7 days:
- Oral lactulose
- 250 mg metronidazole tablets every 8 hours
Intervention: Oral lactulose (Drug)
Metronidazole group
12 patients will receive the following for 7 days:
- Oral lactulose
- 250 mg metronidazole tablets every 8 hours
Intervention: Metronidazole (Drug)
Rifaximine group
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
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
Asmaa Abdel Aziz ElRakaybi
Teaching assistant
Ain Shams University