A Unique Regimen for Treatment of Helicobacter Pylori Infection

Helicobacter Infections Clinical Trial

Official title:

A Unique Quadruple Regimen for of Helicobacter Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03491995
• Other study ID #: Helicobacter study
• Status: Recruiting
• Phase: Phase 3
• First received: April 2, 2018
• Last updated: April 7, 2018
• Start date: April 1, 2018
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2018
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, MD
• Phone: 00201147773440
• Email: sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with eradicated Helicobacter infection	Number of patients with eradicated infection	6 months