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

NCT05664685 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-04-12

No results posted yet for this study

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

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Optimized bismuth quadruple therapy

Scheme that have high dosage of amoxicillin, metronidazole and omeprazole, with bismuth. The rationale of this scheme is that in Chile, amoxicillin resistance is low, clinical metronidazole is low in the doses used and the high doses ob Proton Pump Inhibitor enhanced the antimicrobial drugs

DRUG

Control

Standard eradication therapy using omeprazole, clarithromycin and amoxicillin

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Patricio Medel, MPH · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2023-10-30
Completion
2024-01-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664685 on ClinicalTrials.gov