Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in a High Clarithromycin and Metronidazole Resistance Area Regarding Patients With Peptic Ulcer and Non Ulcer Dyspepsia
NCT ID: NCT07146594
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2025-08-20
2026-05-01
Brief Summary
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The main questions it aims to answer are:
Does the modified bismuth-containing therapy for helicobacter pylori maintains a high eradication profile? What medical problems do participants have when taking the bismuth containing therapy? Researchers will present the eradication percentage of the modified bismuth containing therapy for helicobacter pylori in a difficult to treat population with a high profile of resistance to antibiotics for the treatment of helicobacter pylori separately for first time treated patients or patients with previous failures of other therapies.
Participants will:
Take the modified bismuth containing therapy which consists of four different medications (esomeprazole, amoxicillin, metronidazole, bismuth subcitrate) taken for 14 days in selected timepoints.
Visit the clinic at the end of therapy for checkups and at 6 to 8 weeks after the end of therapy for final evaluation of completed eradication.
Keep a diary of their symptoms and the number of medications taken.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Helicobacter pylori infected
This arm will include patients who have to receive eradication therapy for the first time as first line or experienced patients who have to receive eradication as rescue therapy for third or further line, respectively.
Modified bismuth-containing eradication treatment
After the confirmation of Helicobacter pylori infection, eligible patients whether first line or rescue therapy will be assigned to receive:
\- A modified and optimized bismuth quadruple therapy that comprises: 40 mg of esomeprazole bid, amoxicillin 1g tds, metronidazole 500mg tds and bismuth subcitrate 240mg bid, all medications taken for 14 days.
Esomeprazole will be given at least 30 minutes before meals every 12 hours. Antibiotics will be given after meals every 8 hours and bismuth subcitrate at least 2 hours far from meals every 12 hours.
Interventions
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Modified bismuth-containing eradication treatment
After the confirmation of Helicobacter pylori infection, eligible patients whether first line or rescue therapy will be assigned to receive:
\- A modified and optimized bismuth quadruple therapy that comprises: 40 mg of esomeprazole bid, amoxicillin 1g tds, metronidazole 500mg tds and bismuth subcitrate 240mg bid, all medications taken for 14 days.
Esomeprazole will be given at least 30 minutes before meals every 12 hours. Antibiotics will be given after meals every 8 hours and bismuth subcitrate at least 2 hours far from meals every 12 hours.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Athens Medical Center
OTHER
Responsible Party
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ILIAS XIROUCHAKIS
Dr Ilias Xirouchakis MD, FEBGH
References
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Graham DY, Dore MP, Lu H. Understanding treatment guidelines with bismuth and non-bismuth quadruple Helicobacter pylori eradication therapies. Expert Rev Anti Infect Ther. 2018 Sep;16(9):679-687. doi: 10.1080/14787210.2018.1511427. Epub 2018 Aug 23.
Han Z, Li Y, Kong Q, Liu J, Wang J, Wan M, Lin M, Lin B, Zhang W, Ding Y, Wang S, Mu Y, Duan M, Zuo X, Li YQ. Efficacy of bismuth for antibiotic-resistant Helicobacter pylori strains eradication: A systematic review and meta-analysis. Helicobacter. 2022 Dec;27(6):e12930. doi: 10.1111/hel.12930. Epub 2022 Sep 25.
Megraud F. The challenge of Helicobacter pylori resistance to antibiotics: the comeback of bismuth-based quadruple therapy. Therap Adv Gastroenterol. 2012 Mar;5(2):103-9. doi: 10.1177/1756283X11432492.
Tsay FW, Wu DC, Yu HC, Kao SS, Lin KH, Cheng JS, Wang HM, Chen WC, Sun WC, Tsai KW, Hsu PI. A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e00140-17. doi: 10.1128/AAC.00140-17. Print 2017 Nov.
Georgopoulos SD, Xirouchakis E, Liatsos C, Apostolopoulos P, Kasapidis P, Martinez-Gonzalez B, Laoudi F, Stoupaki M, Axiaris G, Sgouras D, Mentis A, Michopoulos S. Equivalence Trial of the Non-Bismuth 10-Day Concomitant and 14-Day Hybrid Therapies for Helicobacter pylori Eradication in High Clarithromycin Resistance Areas. Antibiotics (Basel). 2024 Mar 20;13(3):280. doi: 10.3390/antibiotics13030280.
Georgopoulos SD, Xirouchakis E, Martinez-Gonzales B, Zampeli E, Grivas E, Spiliadi C, Sotiropoulou M, Petraki K, Zografos K, Laoudi F, Sgouras D, Mentis A, Kasapidis P, Michopoulos S. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area. Eur J Intern Med. 2016 Jul;32:84-90. doi: 10.1016/j.ejim.2016.04.011. Epub 2016 Apr 28.
Olmedo L, Calvet X, Gene E, Bordin DS, Voynovan I, Castro-Fernandez M, Pabon-Carrasco M, Keco-Huerga A, Perez-Aisa A, Lucendo AJ, Rodrigo L, Sarsenbaeva AS, Khlinov IB, Fadieienko G, Zaytsev O, Lanas A, Martinez-Dominguez SJ, Alfaro E, Jonaitis L, Nunez O, Pellicano R, Hernandez L, Gridnyev O, Kupcinskas J, Gasbarrini A, Boltin D, Niv Y, Babayeva G, Marcos-Pinto R, Tepes B, Venerito M, Papp V, Lerang F, Leja M, Phull PS, Marlicz W, Doulberis M, Smith SM, Milivojevic V, Kunovsky L, Mestrovic A, Matysiak-Budnik T, Simsek H, Cano-Catala A, Puig I, Moreira L, Parra P, Nyssen OP, Megraud F, O'Morain C, Gisbert JP; Hp-EuReg investigators*. Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg). Gut. 2024 Dec 10;74(1):15-25. doi: 10.1136/gutjnl-2024-332804.
Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
Chen Q, Long X, Ji Y, Liang X, Li D, Gao H, Xu B, Liu M, Chen Y, Sun Y, Zhao Y, Xu G, Song Y, Yu L, Zhang W, Liu W, Graham DY, Lu H. Randomised controlled trial: susceptibility-guided therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment. Aliment Pharmacol Ther. 2019 Jun;49(11):1385-1394. doi: 10.1111/apt.15273. Epub 2019 Apr 24.
Other Identifiers
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105/2005
Identifier Type: -
Identifier Source: org_study_id
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