An interventional study of Amoxicillin and Metronidazole in Helicobacter Pylori Infection, sponsored by University of Split, School of Medicine. Completed at 1 site in Croatia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment
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.
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%.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 80 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Concomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily.
Drug: Amoxicillin · Drug: Metronidazole · Drug: Clarithromycin · Drug: Pantoprazole 40mg
Tailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily.
Drug: according to antibiogram
14 days 1 gr bid
14 days 500 mg bid
14 days 500 mg bid
40 mg bid 14 days
Also known as: Pantoprazole
according to antibiogram
eradication
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
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
adverse event
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)
Time frame: 1 month after finishing therapy
Plan to share: No
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Split, School of Medicine