Helicobacter pylori. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Conditions
Interventions
Intervention 1: Intervention Group 1: The optimized bismuth quadruple regimen for 14 days: 1- Esomeprazole (Ezonium, manufactured by Abidi Pharmaceutical Company), 20 mg, one capsule every 12 hours 2
Sponsors
Tehran University of Medical Sciences
Dr. Abidi Pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adult patients(18–60 years old) Indication of H.pylori treatment (Peptic ulcer disease, Marginal zone B-cell lymphoma MALT type, Uninvestigated dyspepsia in patients who are under the age of 60 years, Functional dyspepsia, Adult household members of individuals who have a positive non-serological test for H. pylori, Patients taking long term NSAIDs or starting long-term treatment with aspirin, Patients with unexplained iron deficiency anemia, Patients with idiopathic autoimmune thrombocytopenic purpura, Primary and secondary prevention of gastric adenocarcinoma, Current or history of gastric premalignant conditions, Persons with a first degree relative with gastric cancer, Syndromes associated with an increased risk for gastric cancer, Patients with autoimmune gastritis) Informed consent for participating in the study
Exclusion criteria
Exclusion criteria: Prior eradication of h.pylori Taking antibiotics, or bismuth-containing medications within four weeks and proton pump inhibitors (PPIs) within two weeks prior to study entry History of gastric surgery Cancer or severe systemic disease Known sensitivity to drugs used in the treatment protocol Pregnancy breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication of Helicobacter pylori infection. Timepoint: Time of positive Helicobacter pylori test at the beginning of treatment and eradication test six weeks after completion of the fourteen day treatment period. Method of measurement: Negative H. pylori antigen in stool antigen test or negative Urea breath test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients experiencing at least one adverse event during the study. Timepoint: Six weeks after completing the fourteen-day drug treatment. Method of measurement: Structured clinical interview and completion of an adverse event report form with physician.;Percentage of adherence to each medication. Timepoint: 6 weeks after completion of treatment at the final visit. Method of measurement: The patient hands over all of his or her medications during the final visit, and the number of each medication the patient has taken will be recorded on the website. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Mahdi Molaei
Tehran University of Medical Sciences
Outcome results
None listed