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IRCT201201218793N1 IRCT 2012-04-09 Tehran University of Medical Sciences Probiotics in the treatment of Helicobacter Pylori infection Comparison of the effect of antibiotic with antibiotic and probiotic combination in the eradication of Helicobacter Pylori infection in children by a randomized clinical trial 2012-01-21 anticipated 66 Complete https://irct.ir/trial/9281 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A helicobacter pylori infection. Intervention 1: In the intervention group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition, patients in this group receive probiotics for 2 weeks. The probiotic is named RESTORE, the product of Protexin company that contains 7 types of probiotics including Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Lactobacillus Casei, Streptococcus Thermophilus, Bifidobacterium Infantis(child specific), Bifidobacterium breve. This product is given once daily after breakfast. Intervention 2: In the control group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition to the standard regimen, in the control group, the patients receive placebo in the first 2 weeks. Placebo is a product seeming just like the probiotic and is composed of dextrose. This product is prepared by Protexin company and is prescribed once daily after breakfast similar to the RESTORE probiotic.
public Maryam Shoaran
Endoscopy Ward, Children Medical Center Hospital,Qarib St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) +98 21 6692 4545 maryamshoaran@yahoo.com; maryamshoaran1@gmail.com Tehran University of Medical Sciences scientific Ahmad Khodadad
Endoscopy Ward, Children Medical Center Hospital, Qarib St, Keshavarz Blvd
Tehran Iran (Islamic Republic of) +98 21 6692 4545 khodadadmd@yahoo.com; ahmadkhodadad@gmail.com; khodadadmd@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: more than 2 and less than 14 years of age; gastrointestinal symptoms including epigastric tenderness, abdominal pain at night, worsening of abdominal pain by eating, early satiety, abdominal pain or weight loss without a known cause, frequent vomiting and Iron deficiency anemia; confirmation of Helicobacter Pylori infection by rapid urease test or histopathology. Exclusion criteria: use of proton pump inhibitors, H2 receptor antagonists, bismuth compounds and antibiotics in the past 4 weeks; history of surgery on the stomach; sensitivity to certain types of antibiotics; G6PD enzyme deficiency(in these patients the use of furazolidone may lead to anemia ); known underlying disease including renal failure, heart disease or endocrine disease. 2 years 14 years Both B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified Treatment - Drugs Placebo In the intervention group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition, patients in this group receive probiotics for 2 weeks. The probiotic is named RESTORE, the product of Protexin company that contains 7 types of probiotics including Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Lactobacillus Casei, Streptococcus Thermophilus, Bifidobacterium Infantis(child specific), Bifidobacterium breve. This product is given once daily after breakfast. In the control group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg / kg / day/once at morning) are prescribed. Amoxicillin and Furazolidone tablets or syrup forms based on the child's age are given. In addition to the standard regimen, in the control group, the patients receive placebo in the first 2 weeks. Placebo is a product seeming just like the probiotic and is composed of dextrose. This product is prepared by Protexin company and is prescribed once daily after breakfast similar to the RESTORE probiotic. Eradication rate of helicobacter pylori. Timepoint: after two months of the treatment. Method of measurement: stool antigen for helicobacter pylori. Endoscopic finding. Timepoint: at the time of endoscopy. Method of measurement: by the report of the person performing the endoscopy. Adverse effects of the drugs. Timepoint: during the course of treatment. Method of measurement: subjective /asking the patients and parents. Concordance of the result of rapid urease test and pathology report. Timepoint: after the pathology report is prepared. Method of measurement: The comparison of the result of urease test with histopathological report by the researchers. Tehran University of Medical Sciences Approved 2012-01-28 Tehran University of Medical Sciences Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Vali-e-Asr Square, Tehran, Iran. Tehran Iran (Islamic Republic of)