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IRCT20250919067288N1 IRCT 2025-12-26 Ahvaz University of Medical Sciences Comparison of Efficacy and Safety of Two Triple Therapy Regimens for Helicobacter pylori Eradication Comparison of the Efficacy and Safety of Vonoprazan-Based Triple Therapy versus Esomeprazole-Based Triple Therapy for Helicobacter pylori Eradication 2025-10-23 anticipated 184 Complete https://irct.ir/trial/86258 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, interventions are assigned to participants according to a pre-generated randomization list. For allocation concealment, we use the concealment allocation method, which ensures that the assigned group of a participant is not known before the assignment. Opaque, sealed, and sequentially numbered envelopes are used, where each randomization sequence is recorded on a card and placed inside the envelopes in order. To maintain the randomization sequence, the external surface of the envelopes is numbered correspondingly. The envelopes are then sealed and placed sequentially in a box. At the time of participant enrollment, based on the order of eligible participants, an envelope is opened, revealing the treatment group assigned to that participant. After patients are allocated to the two treatment groups following the diagnosis of Helicobacter pylori infection and confirmation of eligibility, participants remain blinded to the type of treatment they receive, Blinding description: This study uses a single-blind design, in which participants are unaware of their assigned treatment group. Allocation to treatment groups is concealed using opaque, sealed, and sequentially numbered envelopes, each containing a pre-generated randomization assignment. Envelopes are opened sequentially upon participant enrollment, revealing the allocated intervention. In addition to participants, clinical caregivers, outcome assessors, and data analysts are blinded to each participant’s treatment allocation to minimize bias. 2 Helicobacter pylori. In this study, after confirming Helicobacter pylori infection and meeting the inclusion criteria, patients are randomly assigned to two treatment groups:Triple Therapy Group A:Vonoprazan 20 mg, twice dailyAmoxicillin 1 g, twice dailyClarithromycin 500 mg, twice dailyTreatment duration: 14 daysTriple Therapy Group B:Esomeprazole 20 mg, twice dailyAmoxicillin 1 g, twice dailyClarithromycin 500 mg, twice dailyTreatment duration: 14 daysAt the end of the treatment period, all patients will undergo a stool Helicobacter pylori antigen test to assess treatment efficacy.Monitoring of adverse effects: During the treatment period, drug-related side effects including headache, dizziness, weakness, confusion, dry mouth, nausea, bloating, and abdominal pain will be recorded through clinical interviews and patient self-report questionnaires.. Yes - There is a plan to make this available What will be shared: In this study, individual participant data (IPD) will be available after completion of the research and following proper de-identification to ensure confidentiality. Data related to the primary outcome (eradication of Helicobacter pylori) and secondary outcomes (adverse drug reactions and other related outcomes) will be shared in the form of anonymized datasets. Other study documents, including the study protocol, questionnaires, and case report forms (CRFs), will also be available upon reasonable request by qualified researchers. Data sharing will only take place after submission of a formal written request and subsequent approval by the Ethics Committee and the research team. When: The study data and documents will be available to eligible researchers starting 6 months after the publication of the final results in peer-reviewed journals, for a period of 3 years. After this period, access will only be granted upon approval by the ethics committee and the research team. To whom: Individuals who are allowed to access the data/documents include academic researchers, postgraduate students, and other qualified investigators who submit a formal request and obtain approval from the ethics committee and the research team. Conditions: The data/documents will be available exclusively for research and scientific purposes, and their use will be permitted only upon formal request, approval from the ethics committee, and strict adherence to participant confidentiality. Where to obtain: To obtain the data/documents, interested researchers may contact the principal investigator at the Department of Internal Medicine, Imam Khomeini Hospital, or Ahvaz Jundishapur University of Medical Sciences. How to obtain: Requests for access to the data/documents must be submitted in writing to the principal investigator. Upon receipt, the research team and ethics committee will review the request. If approved, the data will be provided to the requesting researcher after removal of any identifying information and in accordance with confidentiality regulations. Comments:
public Seyed Saeed Seyedian
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 15794-61357. +98 916 113 7865 seyedian-ss@ajums.ac.ir Ahvaz University of Medical Sciences scientific Seyed Saeed Seyedian
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 15794-61357. +98 61 3222 2114 seyedian-ss@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Their test results indicate a positive Helicobacter pylori infection. 18 years 65 years Both K90-K93 XI Diseases of the digestive system Treatment - Drugs In this study, after confirming Helicobacter pylori infection and meeting the inclusion criteria, patients are randomly assigned to two treatment groups:Triple Therapy Group A:Vonoprazan 20 mg, twice dailyAmoxicillin 1 g, twice dailyClarithromycin 500 mg, twice dailyTreatment duration: 14 daysTriple Therapy Group B:Esomeprazole 20 mg, twice dailyAmoxicillin 1 g, twice dailyClarithromycin 500 mg, twice dailyTreatment duration: 14 daysAt the end of the treatment period, all patients will undergo a stool Helicobacter pylori antigen test to assess treatment efficacy.Monitoring of adverse effects: During the treatment period, drug-related side effects including headache, dizziness, weakness, confusion, dry mouth, nausea, bloating, and abdominal pain will be recorded through clinical interviews and patient self-report questionnaires. The primary outcome variable of this study is eradication of Helicobacter pylori infection after a 14-day treatment course. Eradication will be assessed using the stool Helicobacter pylori antigen test at the end of the treatment period. This variable reflects the efficacy of the interventions (triple therapy based on vonoprazan or esomeprazole). Timepoint: The primary outcome variable, H. pylori eradication, will be measured at the end of the 14-day treatment period. Additionally, drug-related adverse effects will be recorded daily throughout the treatment period to assess patient safety and tolerability of the therapy. Method of measurement: The primary outcome variable, H. pylori eradication, will be measured using the H. pylori stool antigen test (HpSAT) after the 14-day treatment period. Additionally, drug-related adverse effects will be recorded daily through questionnaires and clinical observation to assess treatment safety and tolerability. Drug side effects: including headache, dizziness, weakness, confusion, dry mouth, nausea, bloating, and abdominal pain.Patient adherence to treatment: the extent to which patients follow the 14-day prescribed treatment regimen.Changes in clinical symptoms: including reduction or improvement of gastrointestinal symptoms such as abdominal pain, indigestion, and bloating.Treatment discontinuation rate: the number of patients who discontinue the treatment for any reason. Timepoint: Baseline (before treatment): Recording initial Helicobacter pylori test results and clinical symptoms of the patient.During treatment (Day 7): Monitoring drug side effects and patient adherence to therapy.End of treatment (Day 14): Performing Helicobacter pylori stool antigen test to assess treatment efficacy and recording side effects.Post-treatment follow-up (optional, depending on study design): Evaluating the persistence of eradication and clinical symptoms at a specified time after treatment completion. Method of measurement: Primary outcome (Helicobacter pylori eradication): Assessed using the Helicobacter pylori stool antigen (HpSA) test after the 14-day treatment period.Secondary outcomes (drug side effects): Recorded through clinical interviews and patient-reported questionnaires during and at the end of the treatment period. Side effects include headache, dizziness, weakness, confusion, dry mouth, nausea, bloating, and abdominal pain.Treatment adherence: Evaluated through interviews and review of patient-reported medication intake throughout the treatment period. Ahvaz University of Medical Sciences Approved 2025-09-13 Research Ethics Committee Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)