Efficacy of sequential and standard therapy on Helicobacter pylori eradication in childre
Phase 3
- Conditions
- Helicobacter pylori.Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
- Registration Number
- IRCT2013122515929N1
- Lead Sponsor
- Vice chancellor for research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1- Gastrointestinal symptoms including epigastric tenderness,abdominal pain without reason or at night, pain increase after feeding,early satiety, weight loss without reason, recurrent vomiting, iron deficiency anemia without reason
2- Helicobacter pylori infection documented by pathology or rapid urease test
3- Age below 14 and above 2 years
Exclusion criteria:
1- Drug consumption including proton pomp inhibitor, histamine blockers, bismuth containing drugs and antibiotics during last 4 weeks
2- History of gastric surgery
3- Hypersensitivity to antibiotics
4-Previous known underlying diseases including renal failure or endocrine diseases
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication. Timepoint: Before intervention and 2 months after intervention (1 month after cessation of treatment). Method of measurement: Pathology or rapid urease test (Baharafshan Co.) on the specimen taken during endoscopy before treatment and fecal antigen test of Helicobacter pylori (G.E.N.E.S.I.S , UK) after treatment.
- Secondary Outcome Measures
Name Time Method Treatment Side Effects. Timepoint: 2 Weeks After Beginning of Treatment. Method of measurement: Questionnaire.;Endoscopic presentations of Helicobacter pylori. Timepoint: Before intervention. Method of measurement: Endoscopic view recorded in questionnaire.