Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in childre
Phase 3
Recruiting
- Conditions
- H.pylori Gastritis.B98.0Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
- Registration Number
- IRCT20191022045195N1
- Lead Sponsor
- Qazvin University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Children with Helicobacter pylori infection who are known to be resistant to the first stage of eradication
Exclusion Criteria
Patients who have had a positive history of taking drugs such as antibiotics during the last 4 weeks, Bismuth, proton pump inhibitor, histamine receptor antagonist 2 or non-steroidal anti-inflammatory drug are excluded
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with Helicobacter pylori antigen in the stool sample is negative. Timepoint: Helicobacter pylori antigen assay is performed within 4 to 6 weeks after completion of treatment. Method of measurement: Helicobacter pylori antigen in stool sample by ELISA.
- Secondary Outcome Measures
Name Time Method Percentage of people with side effects while taking the drug. Timepoint: From the beginning of the drug to the end of the study. Method of measurement: Self-expression of the patient, parents or carers.;Percentage of patients who were fully compliant with medication. Timepoint: Up to 4 weeks after starting the drug. Method of measurement: Self-expression of the patient, parents or carers.