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IRCT20230912059417N1 IRCT 2024-01-09 Esfahan University of Medical Sciences Investigating the effect of consecutive treatment with antibiotics and probiotics in functional flatulence Comparison of the effectiveness of Probiotics, Metronidazole and Placebo in patients with abdominal flatulence 2024-01-20 anticipated 80 Complete https://irct.ir/trial/72963 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the study, letter A is written on 40 sheets and letter B is written on 40 sheets, and each is placed in an envelope. Then, each eligible patient who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the two groups according to the envelope selected without the interference of the researcher, Blinding description: Probiotic and placebo drugs were numbered by a person unaware of the study, and the participating patients and the specialist doctor who evaluated the patients' flatulence and the assistant who followed up the patients' symptoms were not aware of the type of drug delivered to the patient, which is probiotic or placebo. 3 Flatulence. Intervention 1: Intervention group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then regflor probiotic containing 200 mg of active lyophilized Bifidobacterium infectis cells is administered once a day 30 minutes before food consumption for 30 days. Intervention 2: Control group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then, a placebo pill is prescribed once a day 30 minutes before meals for 30 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Elham Tabesh
Sofe Blvd, Al-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 tabesh.elham@med.mui.ac.ir Esfahan University of Medical Sciences scientific Elham Tabesh
Sofe Blvd, Al-Zahra Hospital ​
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 tabesh.elham@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years Having functional flatulence (based on Rome III criteria based on history and risk symptoms and functional flatulence diagnostic criteria) Abdominal flatulence feeling at least 3 days a month in the last 3 months The first experience of flatulence is more than 6 months before the study Informed written consent to participate in the study 18 years 70 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 Use of calcium channel blocking drugs in the last 3 months Positive family history for colon cancer Celiac disease Any receipt of antibiotics or probiotics 8 weeks before the study Pregnancy or breastfeeding alcohol consumption R14.3 Flatulence Treatment - Drugs Placebo Intervention group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then regflor probiotic containing 200 mg of active lyophilized Bifidobacterium infectis cells is administered once a day 30 minutes before food consumption for 30 days. Control group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then, a placebo pill is prescribed once a day 30 minutes before meals for 30 days. Bloating severity score. Timepoint: Before of the intervention, 2, 4, 6 and 8 weeks after the start of the study. Method of measurement: Questionnaire IBS- QOL. Quality of life. Timepoint: Before of the intervention, 2, 4, 6 and 8 weeks after the start of the study. Method of measurement: Questionnaire IBS- QOL. Esfahan University of Medical Sciences Approved 2022-09-05 Ethics committee of isfahan University of Medical Sciences Sofe Blvd, Al-Zahra Hospital Isfahan Isfehan Iran (Islamic Republic of)