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IRCT20130812014333N191 IRCT 2022-12-21 Kermanshah University of Medical Sciences The effect of probiotic supplementation on the effectiveness of stomach infection treatment Evaluation of the impact of probiotic supplementation on the efficacy of therapy in eradicating Helicobacter pylori 2023-01-05 anticipated 120 Complete https://irct.ir/trial/67485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using 12 random blocks that will be created using the website https://www.sealedenvelope.com, the samples are studied in each of the groups. The researcher responsible for collecting information is unaware of the type of allocation of samples to the study groups. Coding is done by one of the collaborators of the project. So that a) 12 blocks are considered. b) An English letter is assigned to each of the groups: A to the intervention group, B to the placebo group c) A sequence will be created for a sample size of 120. d) For the random allocation concealment process, ten opaque envelopes (10 constructed blocks) and 120 cards (the size of the total sample) will be made. Inside each envelope, 12 cards will be placed in the sequence in each block. Block numbers were written on each envelope. The name of the desired group will be written on each card in sequence, Blinding description: This study is double-blind; in this way, the participant is not aware of his allocation to the probiotic treatment group or the placebo group; in addition, the researcher is unaware of the members of the two groups. Each dose of medicine is individually packaged and has an identification number. Vials and boxes of medicine and placebo are supplied in completely similar appearance and packaging, which will cause blinding of the participants and the researcher. 2-3 Helicobacter pylori Infection. Intervention 1: The intervention group was given a standard four-drug regimen against Helicobacter (one gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days along with two probiotic tablets (Rist Fermentation Company) daily every twelve hours for Four weeks follow. Intervention 2: The placebo group also received the regimen of four standard anti-helicobacter drugs (One gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days and placebo capsules (Rist Fermentation Company) two tablets daily every twelve hours for Four weeks follow. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Eideh Ramezan Ghanbari
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 eidehghambari63@gmail.com Kermanshah University of Medical Sciences scientific Dr. Homayoon Bashiri
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 hbashirimd@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent dyspepsia symptoms for at least 6 months or more 18 years no limit Both History of kidney failure Patients with a history of taking any antibiotics during the last month and a history of taking proton pump inhibitors and antacids in the last week. Patients with stomach tumors Consumption of alcohol or drugs or non-steroidal anti-inflammatory drugs Having an endoscopic pattern of gastritis Family history of gastrointestinal disease and anti-Helicobacter pylori treatment regimen B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs The intervention group was given a standard four-drug regimen against Helicobacter (one gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days along with two probiotic tablets (Rist Fermentation Company) daily every twelve hours for Four weeks follow. The placebo group also received the regimen of four standard anti-helicobacter drugs (One gram of amoxicillin, 250 mg of metronidazole, 300 mg of bismuth, and 40 mg of pantoprazole) for ten days and placebo capsules (Rist Fermentation Company) two tablets daily every twelve hours for Four weeks follow. Helicobacter pylori infection rate. Timepoint: At the beginning of the study and six weeks after the start of the study. Method of measurement: Using the lateral flow technique. Kermanshah University of Medical Sciences Approved 2022-09-18 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)