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Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

Primary Purpose

Encephalopathy, Hepatic

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Lactulose
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Encephalopathy, Hepatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-70 years

Cirrhosis, defined by a combination of any of the following:

  • Laboratory findings
  • Endoscopic results
  • Ultrasound
  • Histology Overt hepatic encephalopathy

Exclusion Criteria:

  • • Creatinine>1.5 mg/dl

    • Alcohol use within prior 4 weeks
    • Non-hepatic metabolic encephalopathy
    • Hepatocellular carcinoma
    • Degenerative CNS disease
    • Any significant psychiatric illness or other medical comorbidity

Sites / Locations

  • Tanta university - faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lactulose plus nitazoxanide

Lactulose alone

Arm Description

Nitazoxanide dosing: 500 mg tablets twice daily Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day

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

Outcomes

Primary Outcome Measures

Number of patients with total reversal of hepatic encephalopathy

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
August 16, 2017
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02464124
Brief Title
Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
Official Title
A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. Hepatic encephalopathy is caused by accumulation of nitrogenous substances, primarily ammonia, in the blood. In advanced stages it is referred to as hepatic coma which may be preceded by seizures. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Lactulose is nonabsorbable disaccharides that are currently used as first line agents for the treatment of HE. Its action is thought to beconversion to lactic acid and acetic acid resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable, and inhibits ammoniagenic coliform bacteria. 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. Mantry and colleagues showed that the number of hospitalizations and the duration of hospital stays were shortened for patients receiving combination therapy compared with those receiving lactulose monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalopathy, Hepatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lactulose plus nitazoxanide
Arm Type
Experimental
Arm Description
Nitazoxanide dosing: 500 mg tablets twice daily Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Arm Title
Lactulose alone
Arm Type
Active Comparator
Arm Description
Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alenia, Nitclean, Parazoxanide
Intervention Description
• Nitazoxanide dosing: 500 mg tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Laxolac, Duphlac
Intervention Description
• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
Primary Outcome Measure Information:
Title
Number of patients with total reversal of hepatic encephalopathy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years Cirrhosis, defined by a combination of any of the following: Laboratory findings Endoscopic results Ultrasound Histology Overt hepatic encephalopathy Exclusion Criteria: • Creatinine>1.5 mg/dl Alcohol use within prior 4 weeks Non-hepatic metabolic encephalopathy Hepatocellular carcinoma Degenerative CNS disease Any significant psychiatric illness or other medical comorbidity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-elsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-elsalam, lecturer
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem Elfert, Prof
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samah Soliman, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walaa elkhalawany, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rehab elsheshtawi, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mennat-Allah Elsawaf, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Tanta
State/Province
Elgharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abdelsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

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Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

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