Study Results
Results pending
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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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
230 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-01
Study Completion Date
2024-12-31
Brief Summary
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Helicobacter pylori (H. pylori) infection remains a major public health problem, with an estimated prevalence of over 50% worldwide and 60-86% for Portugal. H. pylori is associated with significant morbidity and mortality from peptic ulcerative disease to gastric cancer, whose eradication therapy has proven to be effective in preventing these complications. Factors involved in the development of these conditions include H. pylori virulence, host genetic factors and gut microbiota. Given the increasing pattern of antibiotic resistance evidenced by this bacterium and the scarcity of available antibiotic therapy, both in Portugal and worldwide, there is not enough evidence on the best eradication strategy. Regarding the uncertainties about the potential negative impact of indiscriminate use of eradication therapy on gut microbiota, either by proton pump inhibitors or by antibiotics per se, there is an overriding need for evidence about the real impact of this therapy on oral or gut flora and possible clinical consequences in immunological, metabolic, nutritional and oncological terms.
Objectives: Comparative evaluation of the efficacy of the different quadruple therapy regimens recommended for the H. pylori eradication. Comparative evaluation of the safety profile in terms of clinical, and immunological and gut microbiota impact of the different therapies for the H. pylori eradication.
Objectives: Comparative evaluation of the efficacy of the different quadruple therapy regimens recommended for the H. pylori eradication. Comparative evaluation of the safety profile in terms of clinical, and immunological and gut microbiota impact of the different therapies for the H. pylori eradication.
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Detailed Description
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Introduction: Helicobacter pylori (H. pylori) infection remains a major public health problem, with an estimated prevalence of over 50% worldwide and 60-86% for Portugal. H. pylori is associated with significant morbidity and mortality from peptic ulcerative disease to gastric cancer, whose eradication therapy has proven to be effective in preventing these complications. Factors involved in the development of these conditions include H. pylori virulence, host genetic factors and gut microbiota. Given the increasing pattern of antibiotic resistance evidenced by this bacterium and the scarcity of available antibiotic therapy, both in Portugal and worldwide, there is not enough evidence on the best eradication strategy. Regarding the uncertainties about the potential negative impact of indiscriminate use of eradication therapy on gut microbiota, either by proton pump inhibitors or by antibiotics per se, there is an overriding need for evidence about the real impact of this therapy on oral or gut flora and possible clinical consequences in immunological, metabolic, nutritional and oncological terms.
Objectives: Comparative evaluation of the efficacy of the different quadruple therapy regimens recommended for the H. pylori eradication. Comparative evaluation of the safety profile in terms of clinical, and immunological and gut microbiota impact of the different therapies for the H. pylori eradication.
Methods: Prospective longitudinal multicentre study of total of patients with gastric infection by H. pylori, diagnosed by 13C-urea breath test or histological analysis of gastric biopsies and clinical indication for its eradication, referred to the different participating Portuguese hospital units and a blind randomized controlled clinical trial of the efficacy and safety of the different quadruple therapy regimes recommended for the H. pylori eradication. This study will be carried out in 4 phases: Phase 1 - Recruitment and randomization of patients by the different quadruple eradication schemes with and without bismuth (5 parallel arms); Phase 2 - H. pylori eradication with evaluation of the efficacy and safety rates at 1 month and the absence of reinfection at 12 months after treatment and collection of stool samples before and after the eradication therapy for evaluation of changes in gut microbiota; Phase 3 - Analysis of richness, diversity and uniformity of gut microbiota by DNA sequencing using the hypervariable region of the ribosomal 16S bacteria gene as a taxonomic identification marker and their clinical impact on immunology, metabolism and nutrition at 12 months after the H. pylori eradication therapy; and Phase 4 - Analysis of immunological changes through the study of cell populations by flow cytometry (CD4+, CD8+, B-cell, T-cell, natural killer cells, cells ratio) and cytokines, chemokines and growth factors by xMAP/Luminex before and 12 months after the H. pylori eradication therapy.
Expected results, impact and scientific outputs: Given the high rate of triple therapy inefficacy, high antibiotic resistance and the scarcity and controversy of existing literature on quadruple regimens, there may be relevant differences in the approved quadruple regimens for the H. pylori eradication, being necessary to define which is the most effective and safe in Portugal, decreasing the rate of ineffectiveness and exposure to multiple antibiotics. The homeostasis of gut microbiota is significantly changed after H. pylori eradication and this modification may be substantially different according to the therapeutic scheme used, with clinical implications on immunology, metabolism and nutrition. Thus, a randomized trial to compare quadruple regimens is need, allowing in the future, an individualized selection of the H. pylori eradication regimen, taking into account the higher efficacy and safety and lower gut dysbiosis and its systemic consequences, in short and long term. Modulating oral and gut microbiota therapies, including prebiotics, probiotics, symbiotics, fecal microbiota transplantation and perhaps targeted-immunotherapy may be beneficial as adjuvant therapy to existing H. pylori eradication regimens, in a systematic way or for some therapeutic regimes or risk groups.
Objectives: Comparative evaluation of the efficacy of the different quadruple therapy regimens recommended for the H. pylori eradication. Comparative evaluation of the safety profile in terms of clinical, and immunological and gut microbiota impact of the different therapies for the H. pylori eradication.
Methods: Prospective longitudinal multicentre study of total of patients with gastric infection by H. pylori, diagnosed by 13C-urea breath test or histological analysis of gastric biopsies and clinical indication for its eradication, referred to the different participating Portuguese hospital units and a blind randomized controlled clinical trial of the efficacy and safety of the different quadruple therapy regimes recommended for the H. pylori eradication. This study will be carried out in 4 phases: Phase 1 - Recruitment and randomization of patients by the different quadruple eradication schemes with and without bismuth (5 parallel arms); Phase 2 - H. pylori eradication with evaluation of the efficacy and safety rates at 1 month and the absence of reinfection at 12 months after treatment and collection of stool samples before and after the eradication therapy for evaluation of changes in gut microbiota; Phase 3 - Analysis of richness, diversity and uniformity of gut microbiota by DNA sequencing using the hypervariable region of the ribosomal 16S bacteria gene as a taxonomic identification marker and their clinical impact on immunology, metabolism and nutrition at 12 months after the H. pylori eradication therapy; and Phase 4 - Analysis of immunological changes through the study of cell populations by flow cytometry (CD4+, CD8+, B-cell, T-cell, natural killer cells, cells ratio) and cytokines, chemokines and growth factors by xMAP/Luminex before and 12 months after the H. pylori eradication therapy.
Expected results, impact and scientific outputs: Given the high rate of triple therapy inefficacy, high antibiotic resistance and the scarcity and controversy of existing literature on quadruple regimens, there may be relevant differences in the approved quadruple regimens for the H. pylori eradication, being necessary to define which is the most effective and safe in Portugal, decreasing the rate of ineffectiveness and exposure to multiple antibiotics. The homeostasis of gut microbiota is significantly changed after H. pylori eradication and this modification may be substantially different according to the therapeutic scheme used, with clinical implications on immunology, metabolism and nutrition. Thus, a randomized trial to compare quadruple regimens is need, allowing in the future, an individualized selection of the H. pylori eradication regimen, taking into account the higher efficacy and safety and lower gut dysbiosis and its systemic consequences, in short and long term. Modulating oral and gut microbiota therapies, including prebiotics, probiotics, symbiotics, fecal microbiota transplantation and perhaps targeted-immunotherapy may be beneficial as adjuvant therapy to existing H. pylori eradication regimens, in a systematic way or for some therapeutic regimes or risk groups.
Conditions
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Helicobacter Pylori
Gut Microbiota
Immunology
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
An interventional study is proposed to compare the efficacy and safety of the different approved H. pylori eradication quadruple regimens. Patients will be randomly assigned to the five quadruple regimens arms (A, B, C D and E). All patients will be followed during 12 months. A standardized protocol will be applied for all the groups, differing only in type of quadruple regimen used.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Sampling: Consecutive sampling of incident cases of patients with H. pylori gastric infection and clinical indication for its eradication; Patients will be continuously monitored throughout the study. Regarding the evaluation of oral and gut microbiota and immunological changes, the study will be blinded, since the researchers responsible for sequencing and immunological analysis will not know the therapeutic scheme applied.
Study Groups
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H. pylori eradication scheme A
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 8/8h, for 14 days
Group Type
EXPERIMENTAL
H. pylori eradication scheme A
Intervention Type
DRUG
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 8/8h, for 14 days
H. pylori eradication scheme B
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h, for 14 days
Group Type
EXPERIMENTAL
H. pylori eradication scheme B
Intervention Type
DRUG
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h, for 14 days
H. pylori eradication scheme C
Esomeprazole 40mg bid + bismuth subsalicylate 420mg 6/6h + metronidazole 375mg 6/6h + tetracycline 375mg 6/6h, for 10 days
Group Type
EXPERIMENTAL
H. pylori eradication scheme C
Intervention Type
DRUG
Esomeprazole 40mg bid + bismuth subsalicylate 420mg 6/6h + metronidazole 375mg 6/6h + tetracycline 375mg 6/6h, for 10 days
H. pylori eradication scheme D
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
Group Type
EXPERIMENTAL
H. pylori eradication scheme D
Intervention Type
DRUG
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
H. pylori eradication scheme E
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
Group Type
EXPERIMENTAL
H. pylori eradication scheme E
Intervention Type
DRUG
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
Interventions
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H. pylori eradication scheme A
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 8/8h, for 14 days
Intervention Type
DRUG
H. pylori eradication scheme B
Esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h, for 14 days
Intervention Type
DRUG
H. pylori eradication scheme C
Esomeprazole 40mg bid + bismuth subsalicylate 420mg 6/6h + metronidazole 375mg 6/6h + tetracycline 375mg 6/6h, for 10 days
Intervention Type
DRUG
H. pylori eradication scheme D
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
Intervention Type
DRUG
H. pylori eradication scheme E
Esomeprazole 40mg bid + amoxicillin 1g 12/12h for 7 days, followed by esomeprazole 40mg bid + amoxicillin 1g 12/12h + clarithromycin 500mg 12/12h + metronidazole 500mg 12/12h for 7 days
Intervention Type
DRUG
Other Intervention Names
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Concomitant bismuth-free A
Concomitant bismuth-free B
Pylera
Concomitant with bismuth
Sequential
Hybrid
Eligibility Criteria
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Inclusion Criteria
* Gastric infection by H. pylori by histological examination of gastric biopsies or carbon 13-labeled urea breath test.
Exclusion Criteria
* Age \< 18 years;
* Pregnant, breast-feeding or women of childbearing age who do not comply with effective anticonception measures;
* History of allergy, hypersensitivity or contraindication to the use of H. pylori eradication drugs (antibiotics or proton pump inhibitors);
* History of previous gastrointestinal surgery or neoplasia;
* Previous H. pylori eradication therapies; Antibiotic or probiotic therapies in the month prior to recruitment;
* Use of proton pump inhibitors, other antacids or gastric mucosal protection agents in the 2 weeks prior to recruitment;
* Corticosteroids or immunomodulatory therapy in the month prior to recruitment;
* Immunodeficiency;
* Insulin-treated diabetes mellitus;
* Obesity (Body mass index ≥30Kg/m2);
* Use of laxative therapy in the 15 days prior to recruitment;
* Decompensated heart, liver, kidney or respiratory diseases and;
* Refusal or inability to give informed consent.
* Pregnant, breast-feeding or women of childbearing age who do not comply with effective anticonception measures;
* History of allergy, hypersensitivity or contraindication to the use of H. pylori eradication drugs (antibiotics or proton pump inhibitors);
* History of previous gastrointestinal surgery or neoplasia;
* Previous H. pylori eradication therapies; Antibiotic or probiotic therapies in the month prior to recruitment;
* Use of proton pump inhibitors, other antacids or gastric mucosal protection agents in the 2 weeks prior to recruitment;
* Corticosteroids or immunomodulatory therapy in the month prior to recruitment;
* Immunodeficiency;
* Insulin-treated diabetes mellitus;
* Obesity (Body mass index ≥30Kg/m2);
* Use of laxative therapy in the 15 days prior to recruitment;
* Decompensated heart, liver, kidney or respiratory diseases and;
* Refusal or inability to give informed consent.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Coimbra
OTHER
Sponsor Role
collaborator
Unidade Local de Saúde de Coimbra, EPE
OTHER
Sponsor Role
lead
Responsible Party
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Elisa Gravito-Soares
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Elisa Gravito-Soares, MD
Role: PRINCIPAL_INVESTIGATOR
Unidade Local de Saúde de Coimbra, EPE
Locations
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Centro Hospitalar e Universitário de Coimbra
Coimbra, , Portugal
Site Status
RECRUITING
Countries
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Portugal
Central Contacts
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Facility Contacts
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References
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Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
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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.
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Gao JJ, Zhang Y, Gerhard M, Mejias-Luque R, Zhang L, Vieth M, Ma JL, Bajbouj M, Suchanek S, Liu WD, Ulm K, Quante M, Li ZX, Zhou T, Schmid R, Classen M, Li WQ, You WC, Pan KF. Association Between Gut Microbiota and Helicobacter pylori-Related Gastric Lesions in a High-Risk Population of Gastric Cancer. Front Cell Infect Microbiol. 2018 Jun 19;8:202. doi: 10.3389/fcimb.2018.00202. eCollection 2018.
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RESULT
Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.
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RESULT
Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.
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Lopo I, Libanio D, Pita I, Dinis-Ribeiro M, Pimentel-Nunes P. Helicobacter pylori antibiotic resistance in Portugal: Systematic review and meta-analysis. Helicobacter. 2018 Aug;23(4):e12493. doi: 10.1111/hel.12493. Epub 2018 Jun 17.
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RESULT
Almeida N, Romaozinho JM, Donato MM, Luxo C, Cardoso O, Cipriano MA, Marinho C, Fernandes A, Calhau C, Sofia C. Helicobacter pylori antimicrobial resistance rates in the central region of Portugal. Clin Microbiol Infect. 2014 Nov;20(11):1127-33. doi: 10.1111/1469-0691.12701. Epub 2014 Jul 12.
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RESULT
Graham DY, Lee YC, Wu MS. Rational Helicobacter pylori therapy: evidence-based medicine rather than medicine-based evidence. Clin Gastroenterol Hepatol. 2014 Feb;12(2):177-86.e3; Discussion e12-3. doi: 10.1016/j.cgh.2013.05.028. Epub 2013 Jun 8.
Reference Type
RESULT
Cerqueira RM, Manso MC, Correia MR, Fernandes CD, Vilar H, Nora M, Martins P. Helicobacter pylori eradication therapy in obese patients undergoing gastric bypass surgery--fourteen days superior to seven days? Obes Surg. 2011 Sep;21(9):1377-81. doi: 10.1007/s11695-010-0254-4.
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RESULT
Almeida N, Donato MM, Romaozinho JM, Luxo C, Cardoso O, Cipriano MA, Marinho C, Fernandes A, Calhau C, Sofia C. Beyond Maastricht IV: are standard empiric triple therapies for Helicobacter pylori still useful in a South-European country? BMC Gastroenterol. 2015 Feb 15;15:23. doi: 10.1186/s12876-015-0245-y.
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RESULT
Boal Carvalho P, Magalhaes J, Dias de Castro F, Rosa B, Cotter J. Randomized Controlled Trial for Helicobacter pylori Eradication in a Naive Portuguese Population: Is Sequential Treatment Superior to Triple Therapy in Real World Clinical Setting? Acta Med Port. 2017 Mar 31;30(3):185-189. doi: 10.20344/amp.8072. Epub 2017 Mar 31.
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Cerqueira RM, Correia M, Vilar H, Manso MC. Cumulative Helicobacter Pylori Eradication Rates by Adopting First- and Second- Line Regimens Proposed by the Maastricht IV Consensus in Obese Patients Undergoing Gastric Bypass Surgery. Obes Surg. 2018 Mar;28(3):743-747. doi: 10.1007/s11695-017-2915-z.
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Heimesaat MM, Fischer A, Plickert R, Wiedemann T, Loddenkemper C, Gobel UB, Bereswill S, Rieder G. Helicobacter pylori induced gastric immunopathology is associated with distinct microbiota changes in the large intestines of long-term infected Mongolian gerbils. PLoS One. 2014 Jun 18;9(6):e100362. doi: 10.1371/journal.pone.0100362. eCollection 2014.
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RESULT
Hojo M, Asahara T, Nagahara A, Takeda T, Matsumoto K, Ueyama H, Matsumoto K, Asaoka D, Takahashi T, Nomoto K, Yamashiro Y, Watanabe S. Gut Microbiota Composition Before and After Use of Proton Pump Inhibitors. Dig Dis Sci. 2018 Nov;63(11):2940-2949. doi: 10.1007/s10620-018-5122-4. Epub 2018 May 24.
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Chen L, Xu W, Lee A, He J, Huang B, Zheng W, Su T, Lai S, Long Y, Chu H, Chen Y, Wang L, Wang K, Si J, Chen S. The impact of Helicobacter pylori infection, eradication therapy and probiotic supplementation on gut microenvironment homeostasis: An open-label, randomized clinical trial. EBioMedicine. 2018 Sep;35:87-96. doi: 10.1016/j.ebiom.2018.08.028. Epub 2018 Aug 23.
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Carbo A, Bassaganya-Riera J, Pedragosa M, Viladomiu M, Marathe M, Eubank S, Wendelsdorf K, Bisset K, Hoops S, Deng X, Alam M, Kronsteiner B, Mei Y, Hontecillas R. Predictive computational modeling of the mucosal immune responses during Helicobacter pylori infection. PLoS One. 2013 Sep 5;8(9):e73365. doi: 10.1371/journal.pone.0073365. eCollection 2013.
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Song M, Rabkin CS, Torres J, Kemp TJ, Zabaleta J, Pinto LA, Hildesheim A, Sanchez-Figueroa L, Guarner J, Herrera-Goepfert R, Parsonnet J, Camargo MC. Circulating inflammation-related markers and advanced gastric premalignant lesions. J Gastroenterol Hepatol. 2019 May;34(5):852-856. doi: 10.1111/jgh.14518. Epub 2018 Nov 18.
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Jafarzadeh A, Larussa T, Nemati M, Jalapour S. T cell subsets play an important role in the determination of the clinical outcome of Helicobacter pylori infection. Microb Pathog. 2018 Mar;116:227-236. doi: 10.1016/j.micpath.2018.01.040. Epub 2018 Jan 31.
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Goll R, Cui G, Olsen T, Isaksen V, Gruber F, Husebekk A, Florholmen J. Alterations in antral cytokine gene expression in peptic ulcer patients during ulcer healing and after Helicobacter pylori eradication. Scand J Immunol. 2008 Jan;67(1):57-62. doi: 10.1111/j.1365-3083.2007.02037.x. Epub 2007 Nov 20.
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de Boer WA, Thys JC, Borody TJ, Graham DY, O'Morain C, Tytgat GN. Proposal for use of a standard side effect scoring system in studies exploring Helicobacter pylori treatment regimens. Eur J Gastroenterol Hepatol. 1996 Jul;8(7):641-3.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HpETIP
Identifier Type: -
Identifier Source: org_study_id
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Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
NCT01760824
COMPLETED
NA
H. Pylori Screen-and-treat Study in a Population of Young Adults
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RECRUITING
Helicobacter Pylori Eradication and Follow-up
NCT05061732
RECRUITING
PHASE4
Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.
NCT03571230
UNKNOWN
PHASE4
Helicobacter Pylori Eradication Rates of Bismuth-containing Quadruple Therapy vs Modified Quadruple Therapy in Korea
NCT03665428
COMPLETED
PHASE4
Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection
NCT05718609
UNKNOWN
PHASE4
A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile
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RECRUITING
NA
The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
NCT06591494
NOT_YET_RECRUITING
PHASE2/PHASE3
A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection
NCT02689583
UNKNOWN
NA
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
NCT05549115
UNKNOWN
NA