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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03491995
Other study ID # Helicobacter study
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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