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IRCT20221025056290N1 IRCT 2022-11-03 Kashan University of Medical Sciences The effect of Saccharomyces bulardii in the eradication of Helicobacter pylori The effect of Saccharomyces bulardii as an adjunctive therapy in the eradication of Helicobacter pylori 2022-11-05 anticipated 152 Complete https://irct.ir/trial/66565 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 152 (two groups of 76) and permuted block randomization method (block size=4) (38 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups, A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will continue until the last sample (152nd person). 3 Helicobacter pylori disease. Intervention 1: Intervention group: For fourteen days, he was treated with a four-drug regimen (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day) + Saccharomyces Boulardi probiotic under the Sabolar brand (in capsule form 250 mg twice daily). Intervention 2: Control group: For fourteen days, treated with a regimen of four drugs (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day). 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 There is no more information
public Vahid Kashanian
Diba 12 Ave., Sanat Blvd.
Kashan Iran (Islamic Republic of) 8714893790 +98 31 5541 0386 vhd2369@gmail.com Kashan University of Medical Sciences scientific Dr. Mohsen Razavizadeh
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9333 mohsen_razavizadeh@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) People with Helicobacter pylori infection 19 years no limit Both History of systematic and standardized eradication treatment Kidney failure Taking antibiotics in the last month The person is pregnant and breastfeeding history of neurological disease Weakness in the immune system or taking immunosuppressive drugs B98 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention group: For fourteen days, he was treated with a four-drug regimen (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day) + Saccharomyces Boulardi probiotic under the Sabolar brand (in capsule form 250 mg twice daily) Control group: For fourteen days, treated with a regimen of four drugs (pantaprazole 40 mg twice a day + amoxicillin 1 gram twice a day + clarithromycin 500 mg twice a day + bismuth 240 mg twice a day) Helicobacter pylori eradication. Timepoint: After one month of the last dose of antibiotics, and the patients have not taken PPI drugs for at least two week. Method of measurement: Fecal antigen test. Kashan University of Medical Sciences Approved 2022-09-11 Ethics committee of Kashan University of Medical Sciences Qutb Ravandi Boulevard - Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)