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Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nifuroxazide
Lactulose
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Clinical Hepatic Encephalopathy Staging Scale, Hepatic encephalopathy, Nifuroxazide

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients suffering from liver cirrhosis aging from 18-64 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade II or III) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with Model for End-Stage Liver Disease (MELD) score ≤ 25 and patients are able to swallow. Exclusion Criteria: Patients with neurological or communication problems. Degenerative central nervous system (CNS) disease. Any significant psychiatric illness. Patients with previous intake of nifuroxazide and rifaximin within the last month. Presence of underlying renal impairment (serum creatinine ≥ 2 mg/dL). Alcohol consumption within prior 4 weeks. Non-hepatic metabolic encephalopathy. Anemia with hemoglobin level < 7 g/dL.

Sites / Locations

  • National Hepatology and Tropical Medicine Research Institute (NHTMRI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lactulose plus nifuroxazide

Lactulose alone

Arm Description

Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.

Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.

Outcomes

Primary Outcome Measures

Number of patients achieving complete reversal of hepatic encephalopathy
Complete reversal is defined as the reversibility of HE from grade 2 or 3 to grade 0 or 1 according to West Haven criteria
The time for complete reversal of HE
Evaluating the efficacy of nifuroxazide in improving mental status by calculating CHESS score
Evaluating the efficacy by measuring serum ammonia at baseline and at end of treatment and calculating (CHESS) score at baseline and at end of treatment.

Secondary Outcome Measures

Length of hospital stay
the rate of adverse events occurring during the treatment
Number of patients who experienced adverse events such as abdominal pain, vomiting, nausea, flatulence, anorexia, rash and headache.
Number of patients transferred to ICU

Full Information

First Posted
February 23, 2023
Last Updated
June 15, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05754996
Brief Title
Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy
Official Title
A Randomized Controlled Trial Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Evaluating the efficacy and safety of the efficacy and safety of nifuroxazide in combination with lactulose in comparison to lactulose alone in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy
Detailed Description
Hepatic Encephalopathy (HE) is a central nervous system dysfunction caused by liver insufficiency and/or portosystemic shunting, manifesting as a wide spectrum of neurological or psychiatric abnormalities characterized by alteration of cognitive and motor function. The pathogenesis of hepatic encephalopathy is believed to be due to increased nitrogenous substances, primarily ammonia, in the blood. 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 and non-absorbable antibiotics. Lactulose is nonabsorbable disaccharides that is currently used as first line agents for the treatment of HE. Its action is thought to be due to Colonic metabolism of lactulose to lactic acid results in acidification of the gut lumen. This favors conversion of ammonium (NH4) to ammonia (NH3) and the passage of ammonia from tissues into the lumen. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Lactulose also works as a cathartic, reducing colonic bacterial load. Nifuroxazide is an oral broad-spectrum nitrofuran antibiotic that is commonly used as an intestinal anti-infective agent. It is active against the majority of intestinal bacteria: Gram-positive (Staphylococcus family) and Gram-negative (Enterobacteriaceae family: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Yersinia) and is therefore expected to decrease ammonia production and to reverse the symptoms of HE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Clinical Hepatic Encephalopathy Staging Scale, Hepatic encephalopathy, Nifuroxazide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The recruited patients will be randomly allocated in one of two groups: Group I (The study group): patients will receive oral nifuroxazide: 800 mg daily in 4 divided doses for maximum 7 days and lactulose 30 to 60 mL peroral (PO) three times daily (TID) according to bowel movement (to produce 2 to 3 semisoft stools per day). Group II (The control group): patients will receive the standard treatment : lactulose 30 to 60 mL PO TID according to bowel movement (to produce 2 to 3 semisoft stools per day).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lactulose plus nifuroxazide
Arm Type
Experimental
Arm Description
Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Arm Title
Lactulose alone
Arm Type
Active Comparator
Arm Description
Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Intervention Type
Drug
Intervention Name(s)
Nifuroxazide
Intervention Description
Nifuroxazide dosing : 200 mg capsule four times daily
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools
Primary Outcome Measure Information:
Title
Number of patients achieving complete reversal of hepatic encephalopathy
Description
Complete reversal is defined as the reversibility of HE from grade 2 or 3 to grade 0 or 1 according to West Haven criteria
Time Frame
7 days
Title
The time for complete reversal of HE
Time Frame
7 days
Title
Evaluating the efficacy of nifuroxazide in improving mental status by calculating CHESS score
Description
Evaluating the efficacy by measuring serum ammonia at baseline and at end of treatment and calculating (CHESS) score at baseline and at end of treatment.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
7 days
Title
the rate of adverse events occurring during the treatment
Description
Number of patients who experienced adverse events such as abdominal pain, vomiting, nausea, flatulence, anorexia, rash and headache.
Time Frame
Maximum 7 days
Title
Number of patients transferred to ICU
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from liver cirrhosis aging from 18-64 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade II or III) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with Model for End-Stage Liver Disease (MELD) score ≤ 25 and patients are able to swallow. Exclusion Criteria: Patients with neurological or communication problems. Degenerative central nervous system (CNS) disease. Any significant psychiatric illness. Patients with previous intake of nifuroxazide and rifaximin within the last month. Presence of underlying renal impairment (serum creatinine ≥ 2 mg/dL). Alcohol consumption within prior 4 weeks. Non-hepatic metabolic encephalopathy. Anemia with hemoglobin level < 7 g/dL.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mennat Allah S. Emam
Phone
01007906781
Email
mennatallah.elmlegy@fue.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mennat Allah S. Emam
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Hepatology and Tropical Medicine Research Institute (NHTMRI)
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing Nifuroxazide Plus Lactulose With Lactulose Alone in the Treatment of Hepatic Encephalopathy

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