Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients."

Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

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

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Treatments: Bismuth

Criteria

Inclusion Criteria:

Diagnosed with H. pylori infection by positive Urease test.

Exclusion Criteria:

• Pregnant or lactating women.

• Allergy or history of adverse reaction to the following medications:

• Penicillin

• Salicylate allergy

• Omeprazole

• Has received H. pylori eradication therapy prior to the study.

• Has used PPIs 14 day prior to diagnostic testing

• Use of antibiotics within 4 weeks beforehand.

• History of gastrointestinal bleeding for the last 12 weeks.

• History of partial gastrectomy due to Gastric Cancer

• History of incipient Gastric Cancer resolved by endoscopic resection.

• History of bariatric surgery.

• Serious or malignant diseases with less than 1 year life expectancy.

• History of Clostridium difficile infection.

• History of inflammatory bowel disease.

• Chronic kidney disease, stage 3 or higher.

• Do not sign informed consent.