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IRCT20221216056834N1 IRCT 2023-02-02 Shahid Beheshti University of Medical Sciences The effectiveness of probiotics in eradicating Helicobacter pylori infection of the stomach A clinical trial comparing the effectiveness of probiotics along with standard three drug treatment and standard three drug treatment alone in eradicating Helicobacter pylori in dyspeptic patients between 15 and 45 years old with positive fecal antigen 2023-02-20 anticipated 200 Complete https://irct.ir/trial/68299 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, people are placed in groups using the block blinding method, so that first blocks of 4 are prepared in the form of AABB, ABAB, ABBA, BBAA, BABA, BAAB, and then these blocks are arranged randomly. And people are assigned to two groups according to A and B, and this work is repeated continuously. The website www.sealedenvelope.com is used to generate a random sequence for block randomization, Blinding description: This study is of double-blind type. Blinding for both the participants and the researcher will be done using the identical appearance of the drugs, which will be done by the drug manufacturing company. 3 Helicobacter pylori infection in dyspeptic patients. Intervention 1: Control group: allocation of the standard treatment regimen alone (i.e. pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with a capsule similar to the probiotic capsule without any medicinal properties Made by a contracted pharmacist that is given exactly like probiotic capsules for 2 weeks from the start of the standard regimen. Intervention 2: Intervention group: treatment with three standard drugs (i.e., pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with probiotic capsules made by Bio Fermentation Company (Lactocer). Contains lactobacillus acidophilus and bifidobacterium bifidum, given twice a day from the day the treatment starts for up to 2 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The 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 author of the study through r.talaie@sbmu.ac.ir to receive data and information. How to obtain: Researchers can contact the author of the study through r.talaie@sbmu.ac.ir to receive data and information. Comments:
public Ramin Talaie
Address: The end of Saadat Abad Street - the intersection of Imam Memorial Highway and Saadat Abad
Tehran Iran (Islamic Republic of) 1998734383 021_23515 r.talaie@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Ramin Talaie
Address: The end of Saadat Abad Street - the intersection of Imam Memorial Highway and Saadat Abad
Tehran Iran (Islamic Republic of) 1998734383 021_23515 modarres@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age between 15-40 years Verbal and written consent symptoms of dyspepsia Positive fecal Helicobacter pylori antigen test. 15 years 45 years Both use of any antibiotic in the last 2 weeks consumption of pump inhibitor during the last 1 month History of any proven malignancy history of receiving Helicobacter pylori eradication regimen at any time in the past. B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Control group: allocation of the standard treatment regimen alone (i.e. pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with a capsule similar to the probiotic capsule without any medicinal properties Made by a contracted pharmacist that is given exactly like probiotic capsules for 2 weeks from the start of the standard regimen. Intervention group: treatment with three standard drugs (i.e., pentaprazole 40 mg (b.i.d), amoxicillin 1000 mg (b.i.d), clarithromycin 500 mg (b.i.d)) for 14 days along with probiotic capsules made by Bio Fermentation Company (Lactocer). Contains lactobacillus acidophilus and bifidobacterium bifidum, given twice a day from the day the treatment starts for up to 2 weeks. Fecal antigen. Timepoint: one month after the end of the intervention. Method of measurement: elisa test. Digestive complications. Timepoint: 1 month after the end of the intervention. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2022-10-18 Faculty of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee) Tehran - Velenjak - Shahid Beheshti University of Medical Sciences - Faculty of Medicine tehran Tehran Iran (Islamic Republic of)