Dyspepsia (Upper Gastrointestinal Dyspeptic Disorder / Functional Dyspepsia). Functional dyspepsia
Conditions
Interventions
Intervention 1: Control group (standard quadruple therapy regimen): Participants in the control group will receive the standard quadruple therapy regimen for Helicobacter pylori eradication. This regi
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Positive Helicobacter pylori (H. pylori) fecal antigen test in a patient with dyspepsia Lack of response to usual empirical treatment Age above 18 years Early satiety Persistent anorexia Alarm signs such as anemia or weight loss, family history of gastric cancer, presence of fear of cancer, and suspicion of ulcer. No previous history of H. pylori eradication treatment
Exclusion criteria
Exclusion criteria: Patients who did not consent to treatment. Presence of underlying diseases such as liver cirrhosis, renal failure or severe heart disease, malignancy. History of using steroids, NSAIDs, or antibiotics in the past 2 months. Pregnancy or breastfeeding. G6PD deficiency and gastrointestinal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication (treatment response). Timepoint: antoprazole (a proton pump inhibitor) will be continued until one month after completion of the antibiotic course. Eradication will be assessed one month after the end of the antibiotic course (day 14) and two weeks after discontinuation of pantoprazole by performing the fecal antigen test. Method of measurement: Eradication of infection will be assessed based on the result of the Helicobacter pylori fecal antigen test (H. pylori fecal antigen test), performed at Loghman Hakim Hospital laboratory using the kit manufactured by Pishtaz Teb Company. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment adherence. Timepoint: Treatment adherence will be assessed at the end of the treatment course, i.e., at the day 14 visit. Method of measurement: Treatment adherence at the end of the treatment course (day 14), all patients will be visited, and treatment adherence will be assessed using a structured questionnaire based on the percentage of medications taken during the course. Adherence will be categorized as follows:If the patient has taken more than 90% of the prescribed regimen, adherence will be considered “excellent”.If the patient has taken 70% to 90% of the prescribed regimen, adherence will be considered “good”.If the patient has taken less than 70% of the prescribed regimen, adherence will be considered “poor”.;Drug adverse effects. Timepoint: The incidence and severity of drug adverse effects will be assessed at the end of the treatment course, i.e., at the day 14 visit. Method of measurement: At the same end-of-treatment visit (day 14), the occurrence and severity of drug adverse effects, including abdominal pain, constipation, diarrhea, dizziness, headache, nausea and vomiting, and rash, will be evaluated using a standardized questionnaire. The severity of adverse effects will be classified based on their impact on daily activities as follows:If the adverse effect does not interfere with the patient’s daily activities, it will be considered “mild”.If the adverse effect causes a minor limitation in the patient’s daily activities, it will be considered “moderate”.If the adverse effect causes a profound limitation in the patient’s daily activities, it will be considered “severe”. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Salehi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed