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IRCT20240222061080N1 IRCT 2024-02-28 Qazvin University of Medical Sciences Investigating the effect of probiotics in the treatment of Helicobacter pylori infection Investigating the effect of probiotic composition on the treatment regimen of four drugs for Helicobacter pylori infection 2024-04-03 anticipated 200 Complete https://irct.ir/trial/75684 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random assignment in this study is Balanced Block Randomization. 20 blocks of 10 A, B are numbered from 1 to 10 and numbers 1 to 10 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks, Blinding description: The clinical caregiver receives the drugs that are coded in closed envelopes and injects them into the patients. Coding is done by one of the collaborators of the project. The clinical caregiver, the participant and the analyst are blinded. 3 Patients with Helicobacter pylori infection. Intervention 1: Intervention group: Oral metronidazole 500 mg four times a day / Oral bismuth 300 mg four times a day / Oral amoxicillin 500 mg four times a day / Oral omeprazole 40 mg twice a day / Familact probiotic capsule (Biz Pharmaceutical Company) fermentation) 500 mg twice a day for 14 days. Intervention 2: Control group: Oral metronidazole 500 mg four times a day / Oral bismuth 300 mg four times a day / Oral amoxicillin 500 mg four times a day / Oral omeprazole 40 mg twice a day for 14 days. 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 further information
public Najmeh Khalili Naft Chali
Tavon Square, 22 Bahman Blvd, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34719-76161 +98 28 3379 0620 najmeh.khalili2016@gmail.com Qazvin University of Medical Sciences scientific Najmeh Khalili Naft Chali
Tavon Square, 22 Bahman Blvd, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34719-76161 +98 28 3379 0620 najmeh.khalili2016@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients with Helicobacter pylori infection Age 18 to 75 years 18 years 75 years Both Gastric cancer Kidney and liver failure History of gastric surgery Pregnancy and breastfeeding Unwillingness to participate in the study B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Oral metronidazole 500 mg four times a day / Oral bismuth 300 mg four times a day / Oral amoxicillin 500 mg four times a day / Oral omeprazole 40 mg twice a day / Familact probiotic capsule (Biz Pharmaceutical Company) fermentation) 500 mg twice a day for 14 days Control group: Oral metronidazole 500 mg four times a day / Oral bismuth 300 mg four times a day / Oral amoxicillin 500 mg four times a day / Oral omeprazole 40 mg twice a day for 14 days The recurrence rate of Helicobacter pylori in patients. Timepoint: 4 weeks after treatment. Method of measurement: Fecal antigen test. The incidence of complications and improvement of clinical symptoms in patients. Timepoint: 4 weeks after the end of the intervention. Method of measurement: Clinical examination in terms of pain or burning in the abdomen and the affected area below the ribs and above the navel. Qazvin University of Medical Sciences Approved 2024-02-18 Ethics Committee of Qazvin University of Medical Sciences Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)