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IRCT2013112115475N1 IRCT 2014-10-07 Babol University of Medical Sciences The Eradication of Helicobacter Pylori [H.pylori] in children Comparison efficacy the three- drug regimen of Helicobacter Pylori eradication Amoxicillin, Omeprazole, with Clarithromycin or Azithromycin in children 2014-04-30 anticipated Complete https://irct.ir/trial/14731 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Helicobacter Pylori Infection. Intervention 1: Intervention 1: Azithromycin manufactured by Tehran Shimi Company and Khrazmi 10 mg/kg/day once a day for 6 days using with Amoxicillin manufactured by Farabi Company 50 mg/kg/day every 12 hours for 10 days and Omeprazole developed by Abidy Company 1 mg/kg/day every 12 hours for two weeks. Intervention 2: Intervention 2: Clarithromycin developed by Chemidarou and Rouzdarou Company 15 mg /kg/day every 12 hours for 10 days using with Amoxicillin and Omeprazole. Title: <br /> Eradication of Helicobacter pylori in Children by Triple Therapy Regimens of Amoxicillin, Omeprazole, and Clarithromycin or Azithromycin<br /> Authors:<br /> Mohammad Reza Esmaeili Dooki 1, Hossein Shirdel 1*<br /> <br /> 1- Non-Communicable Pediatric Diseases Research Center, Babol University of Medical Sciences, Babol, IR Iran.<br /> <br /> Correspondence:<br /> Hossein Shirdel, MD, Non-Communicable Pediatric Diseases Research Center, Department of Pediatric gastroenterology, Amirkola Children’s Hospital, Amirkola, Babol, Mazandaran Province, 47317- 41151, IR Iran.<br /> E-mail:<br /> dr.h.shirdel@gmail.com<br /> Tel: +98 1132346963<br /> Fax: +98 1132346963<br /> <br /> Email of first author: esmaeilidooki@yahoo.com<br /> <br /> Running title: Eradication of Helicobacter pylori by Clarithromycin or Azithromycin<br /> <br /> <br /> <br /> Purpose: <br /> The present study aimed to evaluate the effect of classical and azithromycin-containing triple therapy eradication regimen against H. pylori in children, and to determine the level of patients’ tolerance.<br /> Materials and Methods<br /> This clinical trial was performed in 2014 on 2 to 15 years old children referred to the Amirkola Children’s Hospital. All children, whose H. pylori infections were confirmed through multiple biopsies of the stomach and required treatment, were enrolled in the study. H. Pylori-positive patients were treated alternately with two different drug regimens; Group OCA received clarithromycin 7.5 mg/kg/day every 12 hours for 10 days, amoxicillin 50 mg/kg/day every 12 hours for 10 days, and omeprazole 1 mg/kg/day every 12 hours for two weeks, and Group OAA received azithromycin 10 mg/kg/day once a day (before meal) for 6 days along with amoxicillin and omeprazole. Four to six weeks after completion of treatment, patients’ stool was tested for H. pylori through the monoclonal method using the Helicobacter Antigen Quick Kit. <br /> Results<br /> There were no significant differences between the two groups regarding gender and age of patients. Based on ITT analysis, the therapeutic response in the OAA and OCA groups were 56.2% and 62.5%, respectively (p>0.05). Drug intolerance was 9.4% and 3.1% in the OCA and OAA groups, respectively.<br /> Conclusion: <br /> The therapeutic response was seen in more than half of the patients treated with triple therapy of Helicobacter pylori eradication regimen including azithromycin or clarithromycin, and therapeutic response had no significant difference between the two treatment groups.<br /> Key words: Eradication, Helicobacter pylori, Children <br />
public Hossein Shirdel
No 19, Amirkola Children’s Hospital, Amirkola.
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 dr.h.shirdel@gmail.com Amirkola Children’s Hospital scientific Dr Mohammadreza Esmaeili
No 19, Amirkola Children’s Hospital, Amirkola.
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 esmaeilidooki@yahoo.com Amirkola Children’s Hospital Iran (Islamic Republic of) Inclusion criteria: Two to 15 year old children with gastrointestinal symptoms associated with Helicobacter Pylori that need upper Gastro Intestinal whose Gastric biopsy diganosed Helicobacter Pylori Endoscopy and have been referred to the Amirkola Children’s Hospital. Exclusion criteria: Use of antibiotics 2 months ago; children beyond ages of 2 to 15 years; drug allergies to medications used in the study; chronic liver and renal disease; taking non steroidal anti inflammatory drugs; patients who have been previously treated for Helicobacter Pylori. 2 years 15 years Both B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention 1: Azithromycin manufactured by Tehran Shimi Company and Khrazmi 10 mg/kg/day once a day for 6 days using with Amoxicillin manufactured by Farabi Company 50 mg/kg/day every 12 hours for 10 days and Omeprazole developed by Abidy Company 1 mg/kg/day every 12 hours for two weeks. Intervention 2: Clarithromycin developed by Chemidarou and Rouzdarou Company 15 mg /kg/day every 12 hours for 10 days using with Amoxicillin and Omeprazole. The detection Status of Helicobacter Pylori antigen in stool. Timepoint: Four to 6 weeks after the treatment is over. Method of measurement: Check on the stool antigen from Helicobacter Pylori point of view in a Monoclonal Method with Helicobacter Antigen Quick kit. The status of drug tolerance and side effects. Timepoint: Within treatment till the end of treatment span. Method of measurement: Check on the Helicobacter Pylori stool antigen. Babol University of Medical Sciences Approved 2014-04-22 Babol University of Medical Sciences Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran. Babol Iran (Islamic Republic of)