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IRCT20191022045195N1 IRCT 2020-01-08 Qazvin University of Medical Sciences Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children 2019-11-11 anticipated 50 Complete https://irct.ir/trial/43994 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned based on a random number table (with the creation of binary blocks and then based on a random number table) after defining treatment regimens and explaining how they were administered and satisfaction of parents and children over the age of 7 years. A / B therapy will be assigned, Blinding description: We have two therapies so we can build 6 quadruple blocks if we want to randomly block people. As follows: AABB, BBAA, ABAB, BABA, ABBA, BAAB We give each of these blocks a number from 1 to 6 and then randomly select these numbers from 1 to 6, for example if 3 randomly selected ABAB combinations are given, namely the first with treatment A, the second with treatment B, Nephersum is treated with treatment A and the fourth with treatment B.First we must first identify the blocks and number them each block inside an envelope that cannot be seen inside and then using a random number table based on the accident number A number that is the number one envelope is selected. Put the blocks in the envelope by someone who is not involved in the research. 3 H.pylori Gastritis. Intervention 1: Intervention group 1: Patients will be treated with omeprazole, metronidazole, high-dose amoxicillin, and folic acid over a 14-day period. It should be noted that omeprazole is administered as a 1mg / kg capsule in two doses in the morning before breakfast and dinner for 28 days. In a dose of 75mg / kg suspension or capsule, it is administered in two divided doses for 14 days. Folic acid is administered to patients in this group at a dose of 1 mg once daily. The cause of placement of this fourth drug as placebo in this drug group is to prevent any possible bias in the placement of patients in any of the three or four drug groups. .Pharmaceutical Companies Name: Amoxicillin Suspension or Capsule (Manufactured by Farabi Company), Folic Acid as a Tablet (Manufactured by Enamel), Omoperazole as Capsule (Manufactured by Obidi Co.), Metronidazole as Syrup or Tablet (Manufactured by Alborz Drug Company) Bismuth Sub Citrate in tablet form (manufactured by Aria). Intervention 2: Intervention group: Intervention group 2: Patients will be treated with omeprazole, metronidazole, amoxicillin and bismuth subcitrate over a 14-day period. It should be noted that omeprazole is a 1mg / kg capsule in two doses before breakfast and dinner It is prescribed overnight for 28 days. Metronidazole 20 mg / kg syrup or tablet in two divided doses and Amoxicillin 50 mg / kg suspension or capsule in two divided doses and Substratum bismuth drug in 8 mg / kg doses in two divided doses Prescribed. Patients in each group will be monitored appropriately for possible drug use and any possible side effects of the medications used. Patients in each group will be without medication for at least 4 weeks after completion of treatment. Helicobacter pylori antigen screening is performed within 4 to 6 weeks after completion of treatment. If the test results are negative, the effect of helicobacter pylori eradication therapy is considered successful in the second phase of treatment.In the next step, the study data will be analyzed after collecting and completing the relevant checklist and then the results will be compared in each group.It should be noted that in any case of a candidate for Helicobacter pylori eradication treatment, he or she will need treatment, whether it is part of a research project or not. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Rita Bagherian
Shahid Beheshti Boulevard, east of Palestine, Quds Square
Qazvin Iran (Islamic Republic of) 3415914595 +98 28 3333 4807 r.bagherian@qums.ac.ir Qazvin University of Medical Sciences scientific Rita Bagherian
Shahid Beheshti Boulevard, east of Palestine, Quds Square, Quds Hospital
Qazvin Iran (Islamic Republic of) 3415914595 +98 28 3333 4807 r.bagherian@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Children with Helicobacter pylori infection who are known to be resistant to the first stage of eradication 1 year 18 years Both 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 B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention group 1: Patients will be treated with omeprazole, metronidazole, high-dose amoxicillin, and folic acid over a 14-day period. It should be noted that omeprazole is administered as a 1mg / kg capsule in two doses in the morning before breakfast and dinner for 28 days. In a dose of 75mg / kg suspension or capsule, it is administered in two divided doses for 14 days. Folic acid is administered to patients in this group at a dose of 1 mg once daily. The cause of placement of this fourth drug as placebo in this drug group is to prevent any possible bias in the placement of patients in any of the three or four drug groups. .Pharmaceutical Companies Name: Amoxicillin Suspension or Capsule (Manufactured by Farabi Company), Folic Acid as a Tablet (Manufactured by Enamel), Omoperazole as Capsule (Manufactured by Obidi Co.), Metronidazole as Syrup or Tablet (Manufactured by Alborz Drug Company) Bismuth Sub Citrate in tablet form (manufactured by Aria). Intervention group: Intervention group 2: Patients will be treated with omeprazole, metronidazole, amoxicillin and bismuth subcitrate over a 14-day period. It should be noted that omeprazole is a 1mg / kg capsule in two doses before breakfast and dinner It is prescribed overnight for 28 days. Metronidazole 20 mg / kg syrup or tablet in two divided doses and Amoxicillin 50 mg / kg suspension or capsule in two divided doses and Substratum bismuth drug in 8 mg / kg doses in two divided doses Prescribed. Patients in each group will be monitored appropriately for possible drug use and any possible side effects of the medications used. Patients in each group will be without medication for at least 4 weeks after completion of treatment. Helicobacter pylori antigen screening is performed within 4 to 6 weeks after completion of treatment. If the test results are negative, the effect of helicobacter pylori eradication therapy is considered successful in the second phase of treatment.In the next step, the study data will be analyzed after collecting and completing the relevant checklist and then the results will be compared in each group.It should be noted that in any case of a candidate for Helicobacter pylori eradication treatment, he or she will need treatment, whether it is part of a research project or not. 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. 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. Qazvin University of Medical Sciences Approved 2019-11-06 Ethics committee of Qazvin University of Medical Sciences Qazvin - Qods Children's Hospital Qazvin Qazvin Iran (Islamic Republic of)