]>
IRCT20251010067573N1 IRCT 2025-11-10 Kerman University of Medical Sciences Comparison of Vonoprazan-Amoxicillin versus Lansoprazole-Amoxicillin Dual Therapy for Treatment-Resistant H. pylori Comparison of Vonoprazan-Amoxicillin versus Lansoprazole-Amoxicillin Dual Therapy for Treatment-Resistant Helicobacter pylori Infection: A Randomized Clinical Trial 2025-11-16 anticipated 160 Recruiting https://irct.ir/trial/87356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participant allocation to the two treatment arms (Vonoprazan-Amoxicillin and Lansoprazole-Amoxicillin) will be performed using Block Randomization with variable block sizes. This method is used to ensure an approximately equal distribution of participants between the two groups throughout the recruitment period, thereby maintaining balance.The randomization unit is at the Individual level.The random sequence will be generated by an individual independent of the study's executive team, utilizing a statistical software package (such as R or Stata). This output will establish the allocation sequence (Group A or Group B).Allocation concealment will be ensured through the use of sequentially numbered, opaque, and sealed envelopes. These envelopes, containing the group assignment code (A or B), will be prepared according to the random sequence and held by an independent party (e.g., the study pharmacist). After the final confirmation of eligibility criteria by the physician, the next available numbered envelope will be assigned to the participant and opened to reveal the treatment group. This procedure ensures that neither the treating physician nor the participant can foresee the next assignment prior to enrollment, Blinding description: The study will employ a double-blind design, ensuring that both the participants (patients) and the clinical team responsible for treatment and outcome assessment (physicians and assessors) are unaware of the treatment allocation. To implement this, the comparative drugs (Vonoprazan and Lansoprazole) will be prepared and packaged by the study pharmacist in capsules or containers that are identical in appearance, color, and size. These medications will be distributed using a secure, pre-assigned coding system (Allocation Concealment). The code will be held by an independent party and remain unbroken until the final data analysis. The primary outcome assessment (H. pylori eradication status via the Stool Antigen Test) will also be performed by a blinded investigator. 3 Helicobacter pylori infection. Intervention 1: Intervention group: This group will receive the dual therapy regimen consisting of Vonoprazan and Amoxicillin. The Vonoprazan dose is 20 milligrams, twice daily , and the Amoxicillin dose is 1 gram, twice daily. The treatment duration for this group is 14 days, and the administration method is oral. Intervention 2: Control group: This group will receive the dual therapy regimen consisting of Lansoprazole and Amoxicillin. The Lansoprazole dose is 30 milligrams, twice daily , and the Amoxicillin dose is 1 gram, twice daily. The treatment duration for this group is also 14 days, and the administration method is oral. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Masoumeh Rabbani
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Educational and Therapeutic Center
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3261 8239 Mohammadmahdi8754@gmail.com Kerman University of Medical Sciences scientific Behrang Shamsinezhad
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Educational and Therapeutic Center
Kerman Iran (Islamic Republic of) 7616913355 +98 913 140 6752 b.shamsinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Age 18-70 years Confirmed Helicobacter pylori infection by stool antigen test and/or rapid urease test and/or gastric biopsy Failure to respond to at least one previous standard first-line H. pylori eradication regimen (treatment-resistant H. pylori) Written informed consent to participate in the study 18 years 70 years Both Known allergy to vonoprazan, lansoprazole, amoxicillin, or other proton pump inhibitors Pregnancy or lactation History of gastric surgery Severe hepatic or renal disease Use of antibiotics or proton pump inhibitors in the last 4 weeks Gastrointestinal malignancy or inflammatory bowel disease Unwillingness to continue cooperation during the study B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: This group will receive the dual therapy regimen consisting of Vonoprazan and Amoxicillin. The Vonoprazan dose is 20 milligrams, twice daily , and the Amoxicillin dose is 1 gram, twice daily. The treatment duration for this group is 14 days, and the administration method is oral. Control group: This group will receive the dual therapy regimen consisting of Lansoprazole and Amoxicillin. The Lansoprazole dose is 30 milligrams, twice daily , and the Amoxicillin dose is 1 gram, twice daily. The treatment duration for this group is also 14 days, and the administration method is oral. The primary outcome variable of the study is the frequency of Helicobacter pylori eradication. Successful eradication is defined as a negative Stool Antigen Test result during the post-treatment follow-up. Timepoint: The primary outcome variable (Helicobacter pylori eradication) will be measured four weeks after completion of the treatment period. Method of measurement: The primary outcome variable will be measured using the Stool Antigen Test. Kerman University of Medical Sciences Approved 2025-11-08 Ethics Committee in Research, Afzalipour Educational and Therapeutic Center – Kerman University of M Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Educational and Therapeutic Center Kerman Kerman Iran (Islamic Republic of)