University hospital Split
Split, 21000, Croatia
NCT Number: NCT04621487
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Split, 21000, Croatia
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%.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
14 days 1 gr bid
14 days 500 mg bid
14 days 500 mg bid
40 mg bid 14 days
Other names: Pantoprazole
according to antibiogram
Time frame: 1 month after finishing therapy
H.pylori status will be tested 1 month after therapy with a stool antigen test: positive or negative
Time frame: 1 month after finishing therapy
compliance will be measured by counting pills that were taken during therapy, more than or equal to 80% will be considered as good compliance
Time frame: 1 month after finishing therapy
patients will be asked to report any adverse events that occurred during treatment, they will be divided in groups, according to the degree of limitation of daily activities: no adverse events, mild (no limitations of activities), moderate (partially limited activities), severe (completely limited)
University of Split, School of Medicine
Other
A Randomized Controlled Trial: Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection
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