NCT04621487

Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

A Randomized Controlled Trial: Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Split, School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing.

Detailed description

More than half of world population are H.pylori carriers. The infection is mostly acquired in childhood and persists lifelong. A notable risk factor is a lower social and economic status during childhood reflecting mostly poor hygienic standard or small and dense living area. Newly acquired infections in adulthood are a rarity. The reservoir of H. Pylori is the human stomach. H. pylori is considered to be the main pathogen involved in causing benign peptic ulcer and functional dyspepsia as well as gastric cancer. The treatment of H. Pylori infection is currently complicated by an increase in antimicrobial resistance in different parts of the world. Corresponding increase in clarithromycin as well as quinolone and metronidazole resistance poses a major clinical problem and calls for a new approach to treatment. Under such circumstances there is an emerging trend towards personalized eradication therapy. Since H. Pylori infection is an infectious disease its optimal treatment should both theoretically and practically be based on the specific characteristics of the strain and if possible the host of the infection. The aim of such an approach should be a better eradication efficacy. Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing assuming that eradication rate with tailored therapy will be above 90%.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Amoxicillin	14 days 1 gr bid
DRUG	Metronidazole	14 days 500 mg bid
DRUG	Clarithromycin	14 days 500 mg bid
DRUG	Pantoprazole 40mg	40 mg bid 14 days
DRUG	according to antibiogram	according to antibiogram

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-01-15
• Completion: 2020-02-15
• First posted: 2020-11-09
• Last updated: 2020-11-09

Locations

1 site across 1 country: Croatia