A Unique Regimen for Treatment of Helicobacter Pylori Infection

A Unique Quadruple Regimen for of Helicobacter Pylori

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03491995

Enrollment

600

Registered

2018-04-09

Start date

2018-04-01

Completion date

2023-04-01

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Infections

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 .

Interventions

DRUGQuadruple therapy

Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin

DRUGClassic treatment

Omeprazole, amoxycillin, clarithromycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with eradicated Helicobacter infection	6 months	Number of patients with eradicated infection

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, MD

sheriefabdelsalam@yahoo.com00201147773440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026