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IRCT20201225049825N1 IRCT 2021-02-12 Arak University of Medical Sciences Evaluation of the effect of Lactobacillus ruteri in the treatment of Helicobacter pylori with clarithromycin, pantoprazole and amoxicillin regimen Assessment effect of Lactobacillus Reuteri (pyloshot) in H.pylori eradication with clarithromycin, amoxicillin and pantoprazole 2021-01-20 anticipated 76 Complete https://irct.ir/trial/53227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, individuals were divided into groups by block blinding method so that first 4 blocks were prepared as AABB and ABAB, ABBA, BBAA, BABA, BAAB and then these blocks were randomly arranged and individuals According to A and B, they were assigned to two groups and this was repeated continuously, Blinding description: This study is a double-blind study. Blinding will be done for both participants and the researcher using the same appearance of the drugs, which will be done by the drug company. 3 Helicobacter pylori infection. Intervention 1: Intervention group: In this group, in addition to the standard and routine treatment , which includes two antibiotics (amoxicillin one gram twice a day and clarithromycin five hundred mg twice a day) and pantoprazole 40 mg twice a day, pilochat is prescribed for two weeks. In this study, patients in the experimental group used calcium, magnesium and zinc in the form of pilot capsules in addition to Lactobacillus and Bifidobacterium probioticsprobiotics. Intervention 2: Control group: In this study, the control group will receive standard treatment (amoxicillin 1 gr twice daily, clarithromycin 500 mg twice daily, and pantoprazole 40 mg twice daily) with placebo twice daily for two weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Students and researchers can use the data of this study. Where to obtain: Researchers can contact the study author via email at Drhashemiz2018@gmail.com to receive data and information. How to obtain: Request information and data to the author via email Drhashemiz2018@gmail.com Comments:
public Zahra Hashemi
Laleh Alley 8, Hafezieh Boulevard, Hafezieh Town
Arak Iran (Islamic Republic of) ۳۸۱۸۶۶۵۵۶۷ +98 86 3368 3717 Drhashemiz2018@gmail.com Arak University of Medical Sciences scientific Zahra.Hashemi
Laleh Alley 8, Hafezieh Boulevard, Hafezieh Town
Arak Iran (Islamic Republic of) ۳۸۱۸۶۶۵۵۶۷ +98 86 3368 3717 Drhashemiz2018@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Have Helicobacter pylori The patient volunteering to participate in the study, Age 40-75 years Be a resident of Arak. 40 years 75 years Both Having a metastatic cancer Pregnancy Breastfeeding History of failure of previous H.PYLORI treatment Incomplete prescribed treatment regimen Irregular use of medications and non-adherence to the prescribed treatment regimen Previous gastrectomy Suffering from incurable diseases Patients with IHD Chronic renal failure GI bleeding Malignancy Concomitant use of tetracycline, quinolone, bisphosphonates, and levothyroxine (drug interaction) People undergoing chemotherapy Short Bowel Syndrome Anemia and neutropenia fever History of drug and food allergies Hypercalcemia Treatment - Drugs Placebo Intervention group: In this group, in addition to the standard and routine treatment , which includes two antibiotics (amoxicillin one gram twice a day and clarithromycin five hundred mg twice a day) and pantoprazole 40 mg twice a day, pilochat is prescribed for two weeks. In this study, patients in the experimental group used calcium, magnesium and zinc in the form of pilot capsules in addition to Lactobacillus and Bifidobacterium probioticsprobiotics. Control group: In this study, the control group will receive standard treatment (amoxicillin 1 gr twice daily, clarithromycin 500 mg twice daily, and pantoprazole 40 mg twice daily) with placebo twice daily for two weeks. Helicobacter pylori infection using fecal antigen test. Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: Stool antigen test. Arak University of Medical Sciences Approved 2020-09-16 Ethics committee of Arak University of Medical Sciences University of Medical Sciences, Payambar Azam University Complex. Deputy of research and technology Arak Markazi Iran (Islamic Republic of)