A Two Week Nitazoxanidebased Quadruple Regimen

Overview

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer. Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications . However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries. Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Full Title of Study: “A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

Detailed Description

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research. Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Interventions

  • Drug: Nitazoxanide
    • Nitazoxanide 500 mg twice daily
  • Drug: Levofloxacin
    • Levofloxacin 500 mg once daily
  • Drug: Doxycyclin
    • Doxycyclin 100 mg twice daily
  • Drug: Omeprazole
    • Omeprazole 40 mg twice daily

Arms, Groups and Cohorts

  • Experimental: Quadruple therapy
    • Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with eradicated helicobacter
    • Time Frame: 1 year
    • The total number of patients with eradicated helicobacter

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with helicobacter infection. – in whom the standard triple therapy (clarithromycin-based triple therapy) failed Exclusion Criteria:

  • Patients under 18 or over 65 years of age. – Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies – pregnancy/lactation – having contraindication or allergy to any of the study drugs

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tanta University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sherief Abd-Elsalam, Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator – Tanta University
  • Overall Official(s)
    • Sherief Abd-Elsalam, lecturer, Principal Investigator, Tropical medicine-Tanta university hospital
  • Overall Contact(s)
    • Sherief Abd-Elsalam, lecturer, 00201095159522, sherif_tropical@yahoo.com

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