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IRCT20230827059280N1 IRCT 2023-10-09 Esfahan University of Medical Sciences Determining and comparing the effect of probiotic(Sabular) and Rosuvastatin on the success of four-drug treatment to eradicate Helicobacter pylori Determining and comparing the effect of probiotic(Sabular) and Rosuvastatin on the success of four-drug treatment to eradicate Helicobacter pylori in patients referred to the Gastrointestinal Clinic of Al-Zahra Hospital from December 2023 to March 2025 2023-12-22 anticipated 255 Complete https://irct.ir/trial/72483 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Allocation version 2 software will be used. Sampling will be done by the method of alternating blocks of 3: 15 blocks of 6 Each block contains 6 letters from letters A, B, and C including ACABCB CCABAB, BBAACC, BABACA, etc. (three groups of 30) Each patient will be given a card randomly. It is in sealed envelopes and the technician takes the envelopes and delivers them to the patients. For people who have card A, standard H.Pylori first-line therapy (Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth) are given for two weeks. people who have card B, in addition to the four-drug treatment, Sabular probiotic (SaccharomycesBullardi) twice a day is given. For people with card C, Rosuvastatin 10 mg daily is added to the treatment. A month later after the treatment ends, a specific H. Pylori stool Ag test is performed to prove the eradication of Helicobacter, Blinding description: The method of blinding in this study is the single-blind method. Participants are given drugs with a completely similar appearance. , so they are completely unaware of which study group they are in. Researchers, clinical caregivers, and clinical outcome assessors are fully aware of the classification of patients. 3 Helicobacter pylori. Intervention 1: Control group: This group of patients receives the standard 4-drug regimen for Helicobacter pylori including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, placebos, which are similar in appearance to the drugs of the intervention group, are taken orally daily for 2 weeks. Intervention 2: Intervention group: In intervention group 1, the patients are given the standard 4-drug regimen for Heliobacter pylori, including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, the probiotic Sabular (Saccharomyces boulardii) is given twice a day for two weeks at the same time. This drug is similar in appearance to the placebo and the drug given to intervention group 2. Intervention 3: Intervention group: In intervention group 1, the patients are given the standard 4-drug regimen for Heliobacter pylori, including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, Rosuvastatin 10 mg daily for two weeks is given at the same time. This drug is similar in appearance to the placebo and the drug given to intervention group 1. Yes - There is a plan to make this available What will be shared: The participant's data will be fully available after removing personal information, study protocol, statistical analysis plan, informed consent form without personal information, and clinical study report. When: Since the publication of results in authoritative articles To whom: will be available to the public Conditions: There is no limitation to access information and data Where to obtain: Dr. Mohammaad Jafari: m.jafari@mui.ac.ir How to obtain: By sending an e-mail, the applicant states the request and the reason for the request, and the documents will be sent to him within a possible period of one month and after the review of his request Comments:
public Mohammad Jafari
AlZahra Hospital, Sofe Blvd
Isfahan Iran (Islamic Republic of) 7573181746 +98 31 3822 0000 m.jafari@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Jafari
AlZahra hospital, Sofeh Blvd, Isfahan
Isfahan Iran (Islamic Republic of) 7573181746 +98 31 3822 7000 m.jafari@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having a positive stool antigen test for H. pylori Having at least one indication for the treatment of H. Pylori including: 1. Patients with dyspepsia and a positive stool Ag test for H. Pylori, (according to the prevalence >20% of Helicobacter pylori infection in the Iranian population) 2. Patients with resistant dyspepsia and Positive gastric biopsy for Helicobacter in endoscopy 3. Patients with dyspepsia with unknown cause and age less than 60 years who have a positive stool Ag test. 4. Patients with a positive stool Ag test who need long-term treatment with NSAID 5. Patients with early stages of gastric cancer who have undergone resection surgery. 6. Patients with a high risk of gastric cancer (first degree family of a person with gastric cancer, extensive gastritis or severe atrophy of gastric mucosa, history of gastric neoplasm) people treated with gastric acid secretion inhibitors for more than 1 year, the presence of environmental risk factors for stomach cancer or the patient's great fear of stomach cancer) 18 years 80 years Both Pregnancy and breastfeeding at the time of study Immune deficiency Recent history of macrolide use Allergy to penicillin Not currently taking statins and probiotics The presence of contraindications for rosuvastatin use (history of hypersensitivity reaction to rosuvastatin or substances added to the composition of rosuvastatin tablets, increased liver enzymes AST, ALT without a specific cause, acute liver failure, uncompensated liver cirrhosis, pregnancy or breastfeeding) B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Placebo Treatment - Drugs Treatment - Drugs Control group: This group of patients receives the standard 4-drug regimen for Helicobacter pylori including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, placebos, which are similar in appearance to the drugs of the intervention group, are taken orally daily for 2 weeks. Intervention group: In intervention group 1, the patients are given the standard 4-drug regimen for Heliobacter pylori, including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, the probiotic Sabular (Saccharomyces boulardii) is given twice a day for two weeks at the same time. This drug is similar in appearance to the placebo and the drug given to intervention group 2. Intervention group: In intervention group 1, the patients are given the standard 4-drug regimen for Heliobacter pylori, including Esomeprazole plus Clarithromycin plus Amoxicillin plus Bismuth for 2 weeks. In addition to the above drugs, Rosuvastatin 10 mg daily for two weeks is given at the same time. This drug is similar in appearance to the placebo and the drug given to intervention group 1. Helicobacter pylori stool specific antigen test result. Timepoint: Conducting Helicobacter pylori fecal specific antigen test before the start of the study to determine the criteria for the patient to enter the study and 4 weeks after the completion of the 2-week treatment. Method of measurement: Helicobacter pylori stool specific antigen test. Esfahan University of Medical Sciences Approved 2023-07-24 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib St , Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)