Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients

Amro M Hassan; Muhammad Abdel-Gawad; Maie M Mahmoud; Emad Abdelrazzak; Safwat S Sawy; Mohamed A Sayed; Rasha Maree O Ali; Waleed S EL-Nasser; Mohamed Ahmad Younes Hussein; Mohamed Ramadan Izzaldin; Mohammed F Mohammed

doi:10.3855/jidc.20505

Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients

Authors

Amro M Hassan Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt https://orcid.org/0000-0001-8339-6757
Muhammad Abdel-Gawad Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Maie M Mahmoud Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Emad Abdelrazzak Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Safwat S Sawy Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Mohamed A Sayed Tropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Egypt
Rasha Maree O Ali Tropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Egypt
Waleed S EL-Nasser Internal Medicine Department, Faculty of Medicine AL-Azhar University, Assiut, Egypt
Mohamed Ahmad Younes Hussein Clinical Pathology Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Mohamed Ramadan Izzaldin Clinical Pathology Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt
Mohammed F Mohammed Hepatology, Gastroenterology and Infectious Diseases Department, Faculty of Medicine, AL-Azhar University, Assiut, Egypt

DOI:

https://doi.org/10.3855/jidc.20505

Keywords:

H. pylori, nitazoxanide, eradication, resistance

Abstract

Background: Eradication of H. pylori is a challenging issue in many parts of the world including Egypt.

Aim: To evaluate the safety and efficacy of adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen, a single-center phase 4 prospective superiority parallel open-label randomized controlled trial was conducted.

Methodology: Two hundred naïve H. pylori-positive patients were randomly distributed into 4 groups in ratio 1:1:1:1; Group 1: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, omeprazole 20 mg, Group 2: 50 patients were treated by clarithromycin 500mg bid, metronidazole 500mg bid, omeprazole 20 mg bid, group 3: 50 patients were treated by clarithromycin 500mg bid, nitazoxanide 500mg bid, omeprazole 20 mg bid, and group 4: 50 patients were treated by clarithromycin 500mg bid, amoxicillin1gm bid, nitazoxanide 500mg bid, omeprazole 20 mg bid. All patients were treated for 14 days and assessed 4 weeks after treatment.

Results: Adding nitazoxanide to standard clarithromycin based triple therapy achieved a high eradication rate of 84% in intention to treat analysis (ITT), and 89.36% in per protocol (PP) analysis with high significant p (0.01).

Conclusions: adding nitazoxanide as an adjuvant drug to the standard clarithromycin-based regimen is effective and could be used as a first line regimen in the eradication of H. pylori.

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Published

2025-06-30

How to Cite

Hassan AM, Abdel-Gawad M, Mahmoud MM, Abdelrazzak E, Sawy SS, Sayed MA, Ali RMO, EL-Nasser WS, Hussein MAY, Izzaldin MR, Mohammed MF (2025) Efficacy and safety of nitazoxanide based quadruple regimen as first line therapy for treating Helicobacter pylori infected naïve patients. J Infect Dev Ctries 19:843–849. doi: 10.3855/jidc.20505

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Issue

Vol. 19 No. 06: June 2025

Section

Coronavirus Pandemic

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Copyright (c) 2025 Amro M Hassan , Muhammad Abdel-Gawad , Mai M Mahmoud , Emad Abdelrazzak, Safwat S Sawy, Mohamed A Sayed, Rasha M O Ali, Waleed S. EL-Nasser, Mohamed R Izzaldin, Mohamed A Y Hussein, Mohammed F Mohammed

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