10-day Versus 14-day Concomitant PAMC as First-line Treatment Strategy for the Eradication of H. Pylori Infection

• Status: Completed
• Trial end date: 2017-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the International Agency for Research on Cancer. Since then, many consensus conferences and clinical guidelines worldwide have been established for the treatment of H. pylori infection.

Despite H. pylori infecting an estimated 50% of the global population,there is no universally effective regimen in everyday clinical practice. The current European Helicobacter Study Group Guidelines for the first line empirical treatment of the H. pylori infection propose a variety of treatment strategies, as optimal treatment of H. pylori infection requires careful attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended that all H. pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by an international working group of specialists chosen by the Canadian Association of Gastroenterology is of the outmost importance, especially in countries with increased antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to metronidazole.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Metronidazole

Criteria

Inclusion Criteria:

• age >18 or <80 years

• consecutive newly diagnosed H. pylori-infected patients

• endoscopically proven peptic ulcer disease or non-ulcer dyspepsia

• H. pylori infection will be established by at least one positive test among C13-urea breath test (UBT), rapid urease test, and gastric histology.

• patients who have signed the Informed Consent

• patients who will be compliant to study procedures

Exclusion Criteria:

• age <18 or >80 years.

• previous H. pylori eradication therapy

• known allergic history to any of the medications used in our study

• pregnancy or lactation

• ingestion of antibiotics within the prior 4 weeks

• patients with previous gastric surgery

• the coexistence of serious concomitant illness which would not allow patients' compliance (i.e., malignant neoplasms)

• addiction to alcohol or illicit and recreational drugs

• patients who have not signed Informed Consent

• patients who will not comply with study procedures