Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication
NCT ID: NCT05664685
Last Updated: 2024-04-12
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
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
127 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-17
Study Completion Date
2024-01-30
Brief Summary
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This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients."
Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days
Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days
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Detailed Description
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Participants, all with helicobacter pylory test positive, will be recruited into the UC-CHRISTUS Health Network located in the City of Santiago de Chile for this randomized controlled clinical trial.
The intervention group will be treated with Esomeprazole 40 mg every 8 hours, Amoxicillin 1 gr every 8 hours, Metronidazole 500 mg every 8 hours, Bismuth subsalicylate 369 mg every 8 hours. The control group will be treated with Omeprazole 20mg every 12 hours, Amoxicillin 1 gr every 12 hours, Clarithromycin 500 mg every 12 hours, Placebo identical to Bismuth Subsalicylate, 3 times daily.
The primary outcome is H. pylori Eradication. To determine eradication, participants of these study will be invited 8 to 12 weeks after the end of the administered therapy.
As secondary outcomes, will be recorded the Incidence of Adverse Drug Reactions (ADRs) through a questionnaire that will be performed to determine the occurrence of any adverse effect attributable to the therapy. The incidence of bloating, abdominal pain, bitter taste, constipation, diarrhea, dizziness, dyspepsia, epigastric pain, halitosis, headache, loss of appetite, nausea, vomiting, oral ulcers, skin rashes, and drowsiness will be directly recorded. Symptoms reported by participants spontaneously in follow-up phone calls will also be recorded. The time of commencement and duration of the therapy will be recorded. Also will be measured the H. pylori Antibiotic Resistance and Host CYP2C19 polymorphisms determination.
Covariates will be recorded at recruitment. For ADRs and therapeutic adherence telephone follow-up will be performed on days 7 and 14 and 21 after initiation of the therapy. The last follow-up will be performed in person at the time of the UBT.
Sample size calculation
For sample size calculations the following are considered: the expected Eradication rate with the control therapy scheme 82%, the expected eradication rate with the intervention therapy scheme: 97%, the expected absolute difference between therapies 15%, Power 80%, and confidence 95%
This calculation results that 65 participants per branch are needed. Calculations were performed with the statistical program Stata 15. Considering a loss of 10.0%, 72 patients per branch are considered. In addition, the investigators considered 30 additional patients in case the groups resulting from randomization are not balanced, and it is necessary to adjust the effectiveness of the treatments, by 3 variables to be able to make a regression analysis. With this, a total of 102 patients per branch will be included in this study.
Methods used to generate the sequence for patient random assignment to branches For the assignment of participants in the intervention or control branches, a list of random numbers will be used to sequence containers containing the control or intervention treatments. The containers will be delivered to the study participants according to the order in which participants are recruited.
The mechanism used to implement branch random assignment
For the anonymization of the sequence, the research team will delegate the generation of the random sequence and the numbering of the containers to a team that has no participation or knowledge of the design of the study, the collection, or the analysis of data.
Generation of the assignment sequence, recruitment of participants, and assignment of participants to the intervention's responsibilities.
The research team will deliver 204 containers with the intervention or control (102 of each) to 1 member of the UC Pharmacology and Toxicology Program. The member will generate the randomization sequence, number the containers according to their result, and keep the record of the randomization sequence until the data collection is finished, and the statistical analysis is done then the blind opens. In this way responsibilities are assigned to:
A. Generation of the branch assignment sequence: UC Pharmacology and Toxicology Program B. Participant Recruitment: Principal Investigator C. Assignment of participants to the interventions: Principal investigator delivers the containers to the participants, keeping them blind by the randomization and previous numbering of the containers.
Blind status maintenance for participants and research team
To maintain a blind status to branch assignment:
A. Part of the research team that performs patients recruitment B. Part of the research team that performs follows up on participants C. Part of the research team that performs tests for confirmation of eradication of H. pylori D. Part of the research team that performs statistical analysis
Statistical methods used for group comparison of primary and secondary outcomes
The statistical analysis will be performed without knowledge of the therapy scheme assignment, or the clinical evaluation of participants included in the study. P values \<0,05 will be considered statistically significant. The analyses will be carried out under the intention-to-treat (ITT) modality.
Registration and safeguarding of the data collected
Data logging has 3 stages:
1. Recruitment
2. Telephone follow-ups on days 7, 14, and 21 after starting treatment.
3. UBT exam between 8 and 12 weeks after treatment ends.
Each stage will have a physical record on paper, which will be transcribed into the REDCap electronic registry. The paper records will be maintained under lock and key at the Toxicological and Drug Information Center (CITUC), located at Lira 63, second floor.
Regarding the quality of the data recorded
At the time of analysis, a random sample of 10% of the participants will be selected to evaluate the consistency between the physical and electronic records. If there are doubts about the quality of the information, all records will be checked. Anomalous values will also be checked in the physical register.
Data Analysis Plan
Descriptive Statistics
Descriptive statistics will be performed to determine the characteristics of the complete cohort and stratified by experimental branch. The balance of the intervention and control groups will be evaluated. If the balance is not reached, the effect will be directly adjusted with multivariate models.
Primary analysis: Comparison of treatment efficacy
The analysis will perform a comparison of eradication percentages between groups by inferential statistical tests, to determine whether the difference between the groups reaches statistical significance, and also calculate relative risk measures. There will be analyzed variables associated with positive eradication and multivariate analysis of factors associated with eradication using binomial regression.
Secondary analysis: Adverse drug reactions
Adverse reactions
Will be performed descriptive statistics, by type, particular symptom, and temporal evolution. Comparison between control and intervention branches will be analyzed by the magnitude of ADR observed. Evaluation of the association between ADR s with treatment scheme and covariates, by regression, will be performed.
Sensitivity analysis
To evaluate the robustness of the results, the analysis will be repeated in the modality by protocol to compare them with those obtained under the intention-to-treat modality. Secondly, the effect of therapeutic adherence will be evaluated. The analysis will also be stratified by the measured covariates, to evaluate sources of uncertainty, confusion, or possible interactions.
The intervention group will be treated with Esomeprazole 40 mg every 8 hours, Amoxicillin 1 gr every 8 hours, Metronidazole 500 mg every 8 hours, Bismuth subsalicylate 369 mg every 8 hours. The control group will be treated with Omeprazole 20mg every 12 hours, Amoxicillin 1 gr every 12 hours, Clarithromycin 500 mg every 12 hours, Placebo identical to Bismuth Subsalicylate, 3 times daily.
The primary outcome is H. pylori Eradication. To determine eradication, participants of these study will be invited 8 to 12 weeks after the end of the administered therapy.
As secondary outcomes, will be recorded the Incidence of Adverse Drug Reactions (ADRs) through a questionnaire that will be performed to determine the occurrence of any adverse effect attributable to the therapy. The incidence of bloating, abdominal pain, bitter taste, constipation, diarrhea, dizziness, dyspepsia, epigastric pain, halitosis, headache, loss of appetite, nausea, vomiting, oral ulcers, skin rashes, and drowsiness will be directly recorded. Symptoms reported by participants spontaneously in follow-up phone calls will also be recorded. The time of commencement and duration of the therapy will be recorded. Also will be measured the H. pylori Antibiotic Resistance and Host CYP2C19 polymorphisms determination.
Covariates will be recorded at recruitment. For ADRs and therapeutic adherence telephone follow-up will be performed on days 7 and 14 and 21 after initiation of the therapy. The last follow-up will be performed in person at the time of the UBT.
Sample size calculation
For sample size calculations the following are considered: the expected Eradication rate with the control therapy scheme 82%, the expected eradication rate with the intervention therapy scheme: 97%, the expected absolute difference between therapies 15%, Power 80%, and confidence 95%
This calculation results that 65 participants per branch are needed. Calculations were performed with the statistical program Stata 15. Considering a loss of 10.0%, 72 patients per branch are considered. In addition, the investigators considered 30 additional patients in case the groups resulting from randomization are not balanced, and it is necessary to adjust the effectiveness of the treatments, by 3 variables to be able to make a regression analysis. With this, a total of 102 patients per branch will be included in this study.
Methods used to generate the sequence for patient random assignment to branches For the assignment of participants in the intervention or control branches, a list of random numbers will be used to sequence containers containing the control or intervention treatments. The containers will be delivered to the study participants according to the order in which participants are recruited.
The mechanism used to implement branch random assignment
For the anonymization of the sequence, the research team will delegate the generation of the random sequence and the numbering of the containers to a team that has no participation or knowledge of the design of the study, the collection, or the analysis of data.
Generation of the assignment sequence, recruitment of participants, and assignment of participants to the intervention's responsibilities.
The research team will deliver 204 containers with the intervention or control (102 of each) to 1 member of the UC Pharmacology and Toxicology Program. The member will generate the randomization sequence, number the containers according to their result, and keep the record of the randomization sequence until the data collection is finished, and the statistical analysis is done then the blind opens. In this way responsibilities are assigned to:
A. Generation of the branch assignment sequence: UC Pharmacology and Toxicology Program B. Participant Recruitment: Principal Investigator C. Assignment of participants to the interventions: Principal investigator delivers the containers to the participants, keeping them blind by the randomization and previous numbering of the containers.
Blind status maintenance for participants and research team
To maintain a blind status to branch assignment:
A. Part of the research team that performs patients recruitment B. Part of the research team that performs follows up on participants C. Part of the research team that performs tests for confirmation of eradication of H. pylori D. Part of the research team that performs statistical analysis
Statistical methods used for group comparison of primary and secondary outcomes
The statistical analysis will be performed without knowledge of the therapy scheme assignment, or the clinical evaluation of participants included in the study. P values \<0,05 will be considered statistically significant. The analyses will be carried out under the intention-to-treat (ITT) modality.
Registration and safeguarding of the data collected
Data logging has 3 stages:
1. Recruitment
2. Telephone follow-ups on days 7, 14, and 21 after starting treatment.
3. UBT exam between 8 and 12 weeks after treatment ends.
Each stage will have a physical record on paper, which will be transcribed into the REDCap electronic registry. The paper records will be maintained under lock and key at the Toxicological and Drug Information Center (CITUC), located at Lira 63, second floor.
Regarding the quality of the data recorded
At the time of analysis, a random sample of 10% of the participants will be selected to evaluate the consistency between the physical and electronic records. If there are doubts about the quality of the information, all records will be checked. Anomalous values will also be checked in the physical register.
Data Analysis Plan
Descriptive Statistics
Descriptive statistics will be performed to determine the characteristics of the complete cohort and stratified by experimental branch. The balance of the intervention and control groups will be evaluated. If the balance is not reached, the effect will be directly adjusted with multivariate models.
Primary analysis: Comparison of treatment efficacy
The analysis will perform a comparison of eradication percentages between groups by inferential statistical tests, to determine whether the difference between the groups reaches statistical significance, and also calculate relative risk measures. There will be analyzed variables associated with positive eradication and multivariate analysis of factors associated with eradication using binomial regression.
Secondary analysis: Adverse drug reactions
Adverse reactions
Will be performed descriptive statistics, by type, particular symptom, and temporal evolution. Comparison between control and intervention branches will be analyzed by the magnitude of ADR observed. Evaluation of the association between ADR s with treatment scheme and covariates, by regression, will be performed.
Sensitivity analysis
To evaluate the robustness of the results, the analysis will be repeated in the modality by protocol to compare them with those obtained under the intention-to-treat modality. Secondly, the effect of therapeutic adherence will be evaluated. The analysis will also be stratified by the measured covariates, to evaluate sources of uncertainty, confusion, or possible interactions.
Conditions
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Helicobacter Pylori Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists in omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, that consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
For the anonymization of the sequence, the research team will delegate the generation of the random sequence and the numbering of the containers to a team that has no participation or knowledge of the design of the study, the collection or analysis of data.
The research team will deliver 204 containers with the intervention or control (102 of each) to 1 member of the UC Pharmacology and Toxicology Program. They will generate the randomization sequence, number the containers according to their result and keep the record of the randomization sequence until the data collection is finished, and the statistical analysis is done then the blind opens.
The research team will deliver 204 containers with the intervention or control (102 of each) to 1 member of the UC Pharmacology and Toxicology Program. They will generate the randomization sequence, number the containers according to their result and keep the record of the randomization sequence until the data collection is finished, and the statistical analysis is done then the blind opens.
Study Groups
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Intervention
The intervention group will be treated with Esomeprazole 40 mg every 8 hours, Amoxicillin 1 gr every 8 hours, Metronidazole 500 mg every 8 hours, Bismuth subsalicylate 369 mg every 8 hours.
Group Type
EXPERIMENTAL
Optimized bismuth quadruple therapy
Intervention Type
DRUG
Scheme that have high dosage of amoxicillin, metronidazole and omeprazole, with bismuth. The rationale of this scheme is that in Chile, amoxicillin resistance is low, clinical metronidazole is low in the doses used and the high doses ob Proton Pump Inhibitor enhanced the antimicrobial drugs
Control
The control group will be treated with Omeprazole 20mg every 12 hours, Amoxicillin 1 gr every 12 hours, Clarithromycin 500 mg every 12 hours, Placebo identical to Bismuth Subsalicylate, 3 times daily.
Group Type
ACTIVE_COMPARATOR
Control
Intervention Type
DRUG
Standard eradication therapy using omeprazole, clarithromycin and amoxicillin
Interventions
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Optimized bismuth quadruple therapy
Scheme that have high dosage of amoxicillin, metronidazole and omeprazole, with bismuth. The rationale of this scheme is that in Chile, amoxicillin resistance is low, clinical metronidazole is low in the doses used and the high doses ob Proton Pump Inhibitor enhanced the antimicrobial drugs
Intervention Type
DRUG
Control
Standard eradication therapy using omeprazole, clarithromycin and amoxicillin
Intervention Type
DRUG
Other Intervention Names
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Rama Intervención
Rama Control
Eligibility Criteria
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Inclusion Criteria
Diagnosed with H. pylori infection by positive Urease test.
Exclusion Criteria
* Pregnant or lactating women.
* Allergy or history of adverse reaction to the following medications:
* Penicillin
* Salicylate allergy
* Omeprazole
* Has received H. pylori eradication therapy prior to the study.
* Has used PPIs 14 day prior to diagnostic testing
* Use of antibiotics within 4 weeks beforehand.
* History of gastrointestinal bleeding for the last 12 weeks.
* History of partial gastrectomy due to Gastric Cancer
* History of incipient Gastric Cancer resolved by endoscopic resection.
* History of bariatric surgery.
* Serious or malignant diseases with less than 1 year life expectancy.
* History of Clostridium difficile infection.
* History of inflammatory bowel disease.
* Chronic kidney disease, stage 3 or higher.
* Do not sign informed consent.
* Allergy or history of adverse reaction to the following medications:
* Penicillin
* Salicylate allergy
* Omeprazole
* Has received H. pylori eradication therapy prior to the study.
* Has used PPIs 14 day prior to diagnostic testing
* Use of antibiotics within 4 weeks beforehand.
* History of gastrointestinal bleeding for the last 12 weeks.
* History of partial gastrectomy due to Gastric Cancer
* History of incipient Gastric Cancer resolved by endoscopic resection.
* History of bariatric surgery.
* Serious or malignant diseases with less than 1 year life expectancy.
* History of Clostridium difficile infection.
* History of inflammatory bowel disease.
* Chronic kidney disease, stage 3 or higher.
* Do not sign informed consent.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Patricio Medel, MPH
Role: PRINCIPAL_INVESTIGATOR
Pontificia Universidad Catolica de Chile
Locations
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Centro de especialidades médicas Marcoleta UC CHRISTUS
Santiago, Santiago Metropolitan, Chile
Site Status
Centro Médico UC-CHRISTUS San Joaquín
Santiago, Santiago Metropolitan, Chile
Site Status
Countries
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Chile
References
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FitzGerald R, Smith SM. An Overview of Helicobacter pylori Infection. Methods Mol Biol. 2021;2283:1-14. doi: 10.1007/978-1-0716-1302-3_1.
Reference Type
BACKGROUND
McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Rollan A, Arab JP, Camargo MC, Candia R, Harris P, Ferreccio C, Rabkin CS, Gana JC, Cortes P, Herrero R, Duran L, Garcia A, Toledo C, Espino A, Lustig N, Sarfatis A, Figueroa C, Torres J, Riquelme A. Management of Helicobacter pylori infection in Latin America: a Delphi technique-based consensus. World J Gastroenterol. 2014 Aug 21;20(31):10969-83. doi: 10.3748/wjg.v20.i31.10969.
Reference Type
BACKGROUND
Ferreccio C, Rollan A, Harris PR, Serrano C, Gederlini A, Margozzini P, Gonzalez C, Aguilera X, Venegas A, Jara A. Gastric cancer is related to early Helicobacter pylori infection in a high-prevalence country. Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):662-7. doi: 10.1158/1055-9965.EPI-06-0514.
Reference Type
BACKGROUND
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Reference Type
BACKGROUND
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
Reference Type
BACKGROUND
Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.
Reference Type
BACKGROUND
Chiang TH, Chang WJ, Chen SL, Yen AM, Fann JC, Chiu SY, Chen YR, Chuang SL, Shieh CF, Liu CY, Chiu HM, Chiang H, Shun CT, Lin MW, Wu MS, Lin JT, Chan CC, Graham DY, Chen HH, Lee YC. Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands. Gut. 2021 Feb;70(2):243-250. doi: 10.1136/gutjnl-2020-322200. Epub 2020 Aug 13.
Reference Type
BACKGROUND
Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.
Reference Type
BACKGROUND
Tshibangu-Kabamba E, Yamaoka Y. Helicobacter pylori infection and antibiotic resistance - from biology to clinical implications. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):613-629. doi: 10.1038/s41575-021-00449-x. Epub 2021 May 17.
Reference Type
BACKGROUND
Ierardi E, Losurdo G, Fortezza RF, Principi M, Barone M, Leo AD. Optimizing proton pump inhibitors in Helicobacter pylori treatment: Old and new tricks to improve effectiveness. World J Gastroenterol. 2019 Sep 14;25(34):5097-5104. doi: 10.3748/wjg.v25.i34.5097.
Reference Type
BACKGROUND
Kuo CH, Lu CY, Shih HY, Liu CJ, Wu MC, Hu HM, Hsu WH, Yu FJ, Wu DC, Kuo FC. CYP2C19 polymorphism influences Helicobacter pylori eradication. World J Gastroenterol. 2014 Nov 21;20(43):16029-36. doi: 10.3748/wjg.v20.i43.16029.
Reference Type
BACKGROUND
Fallone CA, Chiba N, van Zanten SV, Fischbach L, Gisbert JP, Hunt RH, Jones NL, Render C, Leontiadis GI, Moayyedi P, Marshall JK. The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults. Gastroenterology. 2016 Jul;151(1):51-69.e14. doi: 10.1053/j.gastro.2016.04.006. Epub 2016 Apr 19.
Reference Type
BACKGROUND
Arenas A, Serrano C, Quinones L, Harris P, Sandoval M, Lavanderos M, Sepulveda R, Maquilon S, Echeverria A, Rios C, Fuentes-Lopez E, Rojas L, Jorquera A, Pizarro M, Camargo MC, Riquelme A. High prevalence of clarithromycin resistance and effect on Helicobacter pylori eradication in a population from Santiago, Chile: cohort study and meta-analysis. Sci Rep. 2019 Dec 27;9(1):20070. doi: 10.1038/s41598-019-56399-7.
Reference Type
BACKGROUND
Gonzalez-Hormazabal P, Arenas A, Serrano C, Pizarro M, Fuentes-Lopez E, Arnold J, Berger Z, Musleh M, Valladares H, Lanzarini E, Jara L, Castro VG, Camargo MC, Riquelme A. Prevalence of Helicobacter pylori Antimicrobial Resistance Among Chilean Patients. Arch Med Res. 2021 Jul;52(5):529-534. doi: 10.1016/j.arcmed.2021.01.011. Epub 2021 Feb 12.
Reference Type
BACKGROUND
Camargo MC, Garcia A, Riquelme A, Otero W, Camargo CA, Hernandez-Garcia T, Candia R, Bruce MG, Rabkin CS. The problem of Helicobacter pylori resistance to antibiotics: a systematic review in Latin America. Am J Gastroenterol. 2014 Apr;109(4):485-95. doi: 10.1038/ajg.2014.24. Epub 2014 Mar 4.
Reference Type
BACKGROUND
Reyes D, Ortiz J, Fuentes-Lopez E, Budnik S, Gandara V, Gallardo A, Seydewitz MF, Candia R, Vargas JI, Rollan MP, Godoy J, Rollan A, Mansilla R, Arenas A, Chahuan J, Espino A, Pizarro M, Riquelme A. Quadruple therapies are superior to standard triple therapy for Helicobacter pylori first-line eradication in Chile. Gastroenterol Hepatol. 2022 Aug-Sep;45(7):515-523. doi: 10.1016/j.gastrohep.2021.11.010. Epub 2021 Dec 7. English, Spanish.
Reference Type
BACKGROUND
Kita T, Tanigawara Y, Aoyama N, Hohda T, Saijoh Y, Komada F, Sakaeda T, Okumura K, Sakai T, Kasuga M. CYP2C19 genotype related effect of omeprazole on intragastric pH and antimicrobial stability. Pharm Res. 2001 May;18(5):615-21. doi: 10.1023/a:1011025125163.
Reference Type
BACKGROUND
Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
Reference Type
BACKGROUND
Valencia-Monsalvez F, Mendoza-Parra S, Luengo-Machuca L. [Evaluation of Morisky medication adherence scale (mmas-8) in older adults of a primary health care center in Chile]. Rev Peru Med Exp Salud Publica. 2017 Apr-Jun;34(2):245-249. doi: 10.17843/rpmesp.2017.342.2206. Spanish.
Reference Type
BACKGROUND
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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220710002
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE4
Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
NCT02159976
COMPLETED
NA
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
NCT01760824
COMPLETED
NA
Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses
NCT05431075
COMPLETED
PHASE4
Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection
NCT01906879
UNKNOWN
PHASE4
Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
NCT05100446
UNKNOWN
EARLY_PHASE1
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
NCT07104318
NOT_YET_RECRUITING
PHASE3
Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment
NCT04667299
UNKNOWN
PHASE4
Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori
NCT06299605
ENROLLING_BY_INVITATION
NA
Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication
NCT02541864
COMPLETED
NA
Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection
NCT02576236
UNKNOWN
NA
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies
NCT04209933
COMPLETED
PHASE4
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
NCT07139366
RECRUITING
PHASE4
Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication
NCT01306786
COMPLETED
NA
Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection
NCT03361267
UNKNOWN
NA
Tailored Therapy for Clarithromycin-Resistant H. Pylori
NCT03431688
COMPLETED
NA
Bismuth Quadruple Therapy Versus Standard Triple Therapy
NCT06143124
RECRUITING
PHASE4
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
NCT02395458
COMPLETED
PHASE4
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection
NCT00520949
COMPLETED
NA
Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.
NCT04090021
UNKNOWN
PHASE4