Helicobacter pylori. XI Diseases of the digestive system
Conditions
Interventions
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
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Their test results indicate a positive Helicobacter pylori infection.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Saeed Seyedian
Ahvaz University of Medical Sciences
Outcome results
None listed