Study Comparing Sequential and Concomitant Therapy for Helicobacter Pylori Eradication in Routine Clinical Practice

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Helicobacter pylori is the main cause of chronic gastritis, peptic ulcer and gastric tumors (adenocarcinoma and lymphoma). The cure of the H. pylori infection prevents recurrence of duodenal and gastric ulcer and improves dyspepsia in a significant proportion of cases, so it is cost-effective.

Eradication therapy has changed over time. The usually recommended pattern in the consensus conferences has traditionally been triple therapy, composed by the combination of 2 antibiotics (clarithromycin plus amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7-14 days. Recent meta-analyses have that the current global eradication rate after standard triple therapy is less than 80%. Several European studies have found even lower eradication rates, with 35-40% of cases resulting in treatment failure. Treatment failure leads to a second treatment and a new diagnostic test to confirm eradication.

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

Details

• Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Treatments: Amoxicillin; Clarithromycin; Metronidazole

Criteria

Inclusion Criteria:

• Inclusion of patients with dyspepsia or peptic gastroduodenal ulcer for whom eradication treatment is indicated.

• Requirement of confirmation of the diagnosis of H. pylori infection by at least one positive test out of the following: breath test, histology, rapid urease test or culture.

Exclusion Criteria:

• Age less than 18 years.

• Advanced chronic disease or any other pathology that prevents attending controls and follow up.

• Allergy to any of the antibiotics in the treatment.

• Previous gastric surgery

• Pregnancy and lactation.

• History of alcohol or drug abuse.

• Previous eradication treatment.

• Consumption of antibiotics or bismuth salts during the last 4 weeks