A Unique Regimen for Treatment of Helicobacter Pylori Infection

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 3

Conditions: Helicobacter Infections

Treatments: Drug: Classic treatment; Drug: Quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03491995

Helicobacter study

Details and patient eligibility

About

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 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 .

Enrollment: 600 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Quadruple therapy

Experimental group

Description:

Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin

Treatment:

Drug: Quadruple therapy

Classic treatment

Active Comparator group

Description:

Omeprazole, clarithromycin, amoxicillin

Treatment:

Drug: Classic treatment