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IRCT20200601047621N1 IRCT 2020-06-18 Esfahan University of Medical Sciences Probiotics Bismuth Subsalicylate and Abdominal Bloating Evaluation and comparison of the therapeutic effects of probiotics, Bismuth subsalicylate and placebo in patients with abdominal bloating in patients referring to gastrointestinal clinic in Khorshid hospital. 2020-07-29 anticipated 100 Complete https://irct.ir/trial/48629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 0-33 for group 1, numbers 34-66 for group 2, and numbers 67-99 for group 3. 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 3 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. After the course of treatment, to assess the effectiveness of the medication, the assessor does not know which patient has been treated with what medication and only fills in the information related to the questionnaires. 2-3 Abdominal Bloating. Intervention 1: Intervention group1: 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. Intervention 2: Intervention group2: Subsalicyte bismuth receptor. Patients in this group will receive 120 mg of bismuth subsalicylate tabletsproduced by Abo-reyhan company every 12 hours after a meal. The duration of treatment will be 8 weeks. Intervention 3: Control group: Plasbo recipient. Patients in this group will use placebo tablets containing starch or a similar appearance to the tablets used in the other two groups for 8 weeks. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have been identified When: Late 2020 To whom: Researchers working in academic and scientific institutions Conditions: Free and on Web Individuals can use the documents by visiting the research sites and the website of Isfahan University of Medical Sciences Where to obtain: Free and on Web. Individuals can use the documents by visiting the website of Isfahan University of Medical Sciences and submitting an application How to obtain: Apply online through the university website and issue a license within about 2 weeks after approval and apply for data access Comments:
public Maryam Soheilipour
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 6719674255 +98 31 3729 4225 maryamsoheilip@med.mui.ac.ir Esfahan University of Medical Sciences scientific Maryam Soheilipour
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 6719674255 +98 31 3729 4225 maryamsoheilip@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All of the Patients with Abdominal Bloating Age between 20 and 50 years Feeling bloated for at least 3 days a month for the last 3 months The first experience of bloating more than 6 months ago 20 years 50 years Both Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract Any serious physical problems or illness, such as inflammation or malignancy Use of calcium channel blockers in the last 3 months Severe stress in the last 6 months Positive family history for Colon Concert History of inflammatory diseases Lactase deficiency disease Celiac disease R14.3 Flatulence Treatment - Drugs Treatment - Drugs Placebo Intervention group1: 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. Intervention group2: Subsalicyte bismuth receptor. Patients in this group will receive 120 mg of bismuth subsalicylate tabletsproduced by Abo-reyhan company every 12 hours after a meal. The duration of treatment will be 8 weeks. Control group: Plasbo recipient. Patients in this group will use placebo tablets containing starch or a similar appearance to the tablets used in the other two groups for 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 2020-05-31 Ethics committee of Isfahan University of Medical Sciences No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)