A Unique Regimen for Treatment of Helicobacter Pylori Infection

Phase 3

• Conditions: Helicobacter Infections
• Interventions: Drug: Classic treatment; Drug: Quadruple therapy

• Registration Number: NCT03491995
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

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

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 .

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-01
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-02
• Last Update Submitted: 2018-04-07
• Study First Posted: 2018-04-09
• Last Update Posted: 2018-04-10
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic treatment	Classic treatment	Omeprazole, clarithromycin, amoxicillin
Quadruple therapy	Quadruple therapy	Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin

Primary Outcome Measures

Name	Time	Method
Number of patients with eradicated Helicobacter infection	6 months	Number of patients with eradicated infection

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt