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IRCT20220916055971N1 IRCT 2023-03-22 Esfahan University of Medical Sciences Metronidazole and Probiotics in functional flatulence patients Investigating the therapeutic effect of Probiotics along with Metronidazole and Probiotics alone in patients with functional flatulence 2023-05-05 anticipated 45 Complete https://irct.ir/trial/68633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (for example, top or bottom) and the researcher's second default is to consider numbers 0-45 for group 1, numbers 46-90 for group 2. The researcher then touches one of the numbers and moves in a predetermined direction, recording the numbers and assigning them to the groups, Blinding description: In this study, patients will be assigned to 2 groups. Patients are not relieved of the drug content they receive because the appearance of all medications is the same. Clinical caregivers who give medications to patients also did not know what medication to give. 2-3 Abdominal Bloating. Intervention 1: Intervention group 1: At first, for 2 weeks, they will receive 500 mg Metronidazole Tablet of Pars Daru three times a day, and after 2 weeks, they will receive 500 mg FamiLact Probiotic Tablet of Zisttakhmir Company, every 12 hours after the main meals for one month. Intervention 2: Intervention group 2: Probiotic recipient. Patients on this group receive Familact probiotic tablets from the Zist-takhmir company, containing 7 strains of bacteria (lactobacilli, bifidobacteria, streptococcus thermophilus), will receive every 12 hours after the main meal, and the duration of treatment will be 8 weeks. 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 Compliance with ethical considerations
public Dr. Maryam Soheilipour
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 0983136201991 maryamsoheilip@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Maryam Soheilipour
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 0983136201991 maryamsoheilip@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 50 years Having functional abdominal distention according to the Rome III criteria The first experience of bloating is more than 6 months before the study Abdominal bloating feeling at least 3 days a month in the last 3 months Consent to participate in the study 20 years 50 years Both Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract Any serious physical problem or disease such as inflammation or malignancy ŮŽAbnormal laboratory data Use of Calcium Channel Blocker drugs in the last 3 months Severe stress in the last 6 months Positive family history for colon cancer Pregnancy or breastfeeding\ R14.3 Flatulence Treatment - Drugs Treatment - Drugs Intervention group 1: At first, for 2 weeks, they will receive 500 mg Metronidazole Tablet of Pars Daru three times a day, and after 2 weeks, they will receive 500 mg FamiLact Probiotic Tablet of Zisttakhmir Company, every 12 hours after the main meals for one month. Intervention group 2: Probiotic recipient. Patients on this group receive Familact probiotic tablets from the Zist-takhmir company, containing 7 strains of bacteria (lactobacilli, bifidobacteria, streptococcus thermophilus), will receive every 12 hours after the main meal, and the duration of treatment will be 8 weeks. Abdominal Bloadting. Timepoint: Before the start of the study, 2 weeks after the start of the study, 4 weeks after the start of the study, 6 weeks after the start of the study and 8 weeks after the start of the study. Method of measurement: Questionnaire for bloating and IBS-QOL questionnaire. Esfahan University of Medical Sciences Approved 2022-09-27 Ethics Committee in Research, School of Medicine, Isfahan University of Medical Sciences Al-Zahra Medical Education Center, Sofe Ave ,Isfahan Isfahan Isfehan Iran (Islamic Republic of)