A Unique Regimen for Treatment of Helicobacter Pylori Infection

Overview

The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori. However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Full Title of Study: “A Unique Quadruple Regimen for of Helicobacter Pylori”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 1, 2023

Detailed Description

Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Interventions

  • Drug: Quadruple therapy
    • Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
  • Drug: Classic treatment
    • Omeprazole, amoxycillin, clarithromycin

Arms, Groups and Cohorts

  • Experimental: Quadruple therapy
    • Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin
  • Active Comparator: Classic treatment
    • Omeprazole, clarithromycin, amoxicillin

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with eradicated Helicobacter infection
    • Time Frame: 6 months
    • Number of patients with eradicated infection

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent Exclusion Criteria:

  • Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sherief Abd-Elsalam
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Sherief Abd-Elsalam, Investigator – Tanta University
  • Overall Official(s)
    • Ayman Yousry, Prof, Principal Investigator, Head of Hepatology and infectious diseases dept.-Cairo University
    • Walied El-Hossary, MD, Study Director, Hepatology and infectious diseases dept.-Cairo University
    • Mohamed Alboraie, MD, Study Chair, Internal Medicine dept.-Alazhar University
    • Sherief Abd-Elsalam, MD, Study Chair, Hepatology and Infectious diseases- Tanta University
    • Asem Elfert, Prof, Study Chair, Hepatology and Infectious diseases- Tanta University
    • Hussein A Elamin, Prof, Study Chair, Internal Medicine-Assuit University
    • Mohamed Adel Elbasiony, MD, Study Chair, Internal Medicine- Mansoura University
  • Overall Contact(s)
    • Sherief Abd-Elsalam, MD, 00201147773440, sheriefabdelsalam@yahoo.com

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