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IRCT20200106046021N1 IRCT 2020-01-14 Birjand University of Medical Sciences The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects: a Double-Blind Placebo-Controlled Randomized Clinical Trial 2020-01-08 anticipated 156 Complete https://irct.ir/trial/44865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected as Available and then Randomly Assigned to Treatment Groups using the Oblique Coin, Blinding description: In this study, All Participants, Physicians Responsible for Treating Patients, the Principal Investigator, and the Collectors of Patient information and data on outcome variables, Blinding be. 3 Gastric infection with Helicobacter pylori. Intervention 1: Control group: Taking placebo capsules that are completely identical to supplements in weight, size, shape and taste for 14 days in combination with the standard four-dose regimen for Helicobacter pylori infection for 14 days. The dosage is one after breakfast and one after dinner. Intervention 2: First Intervention group: They take supplemental Saccharomyces Bullardi (DAILYEAST®) for 14 days in combination with the usual four-dose regimen for Helicobacter pylori infection, one after breakfast and one after dinner. Intervention 3: Second Intervention group: Supplement DSMZ 17648 Lactobacillus Reuteri (PYLOSHOT) strain for 14 days in combination with routine quadruple therapy for Helicobacter pylori infection, two after breakfast and two after dinner. Yes - There is a plan to make this available What will be shared: Age data of the participants, symptoms that led to the gastrointestinal clinic, the reason for the endoscopy, and the outcome after the end of the study were shared. Participants are unrecognizable. When: Start access period immediately after printing results. To whom: Researchers working in academic and scientific institutions Conditions: If relevant, study compares the treatment regimens of Helicobacter pylori infection and the use of probiotics in treatment. Where to obtain: Send mail to Dr. Tahmineh Tavakoli as a Clinical Trial Examiner. Birjand University of Medical Sciences. tahminetavakoli95238@yahoo.com How to obtain: Email and send request Comments:
public Nushin Naghibzadeh
Second Floor,Valiasr Hospital,Ghaffari Ave.,Department of Education
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3162 2035 nushin_naghibzadeh@bums.ac.ir Birjand University of Medical Sciences scientific Dr.Tahmine Tavakoli
Ghaffari Street, Valiasr Hospital
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3162 2035 tahminetavakoli95238@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Symptoms of H. pylori-positive as Confirmed by Clinical, Endoscopic, and Pathological Reports. 15 years no limit Both Pregnancy and lactation Patients with Liver, CardioPulmonary, Renal, Neoplastic Diseases People taking Proton Pump Inhibitors, Bismuth Salts, or Probiotics for the past 4 weeks and any Immuno Suppressive Drugs Surgery such as Gastrectomy or Gastric Bypass The existence of Autoimmune Diseases IBD (Inflammatory Bowel Disease) Organ Transplant Weight loss over 3kg over the past three months Previous History of Helicobacter Pylori Eradication Oral Antibiotic use in less than 3 months Alcohol abuse Participate in Other Clinical Trials Concurrently Placebo Treatment - Drugs Treatment - Drugs Control group: Taking placebo capsules that are completely identical to supplements in weight, size, shape and taste for 14 days in combination with the standard four-dose regimen for Helicobacter pylori infection for 14 days. The dosage is one after breakfast and one after dinner. First Intervention group: They take supplemental Saccharomyces Bullardi (DAILYEAST®) for 14 days in combination with the usual four-dose regimen for Helicobacter pylori infection, one after breakfast and one after dinner. Second Intervention group: Supplement DSMZ 17648 Lactobacillus Reuteri (PYLOSHOT) strain for 14 days in combination with routine quadruple therapy for Helicobacter pylori infection, two after breakfast and two after dinner. Mean recovery time in study groups. Timepoint: 2 and 6 weeks after the end of treatment. Method of measurement: Stool Antigen Test. Frequency distribution of treatment side effects in study groups. Timepoint: During treatment weekly. Method of measurement: Using the questionnaire. ZIST TAKHMIR Pharmaceutical company Birjand University of Medical Sciences ZIST TAKHMIR Pharmaceutical company Approved 2020-01-05 Ethics committee of Birjand University of Medical Sciences Second floor, Valiasr Hospital, Ghaffari Ave., Department of Education Birjand South Khorasan Iran (Islamic Republic of)