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IRCT20150706023084N13 IRCT 2021-12-29 Faradaro Fanavar Mehr Company Evaluation of the effect of Lactobacillus reuteri probiotic in functional constipation Evaluation of the effectiveness of Lactobacillus reuteri probiotic versus placebo in the treatment of functional constipation in children 3 to 18 years old 2022-01-21 anticipated 160 Complete https://irct.ir/trial/56533 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is performed in two parts. In the first part, the studied drug (probiotic or placebo) along with polyethylene glycol is given to patients (as standard treatment) for 28 days, and in the second part, the polyethylene glycol drug is discontinued and only probiotic or placebo is given to the patient for 28 days, Randomization description: After receiving the drug and placebo packages from Farabiotic Company, 160 codes were randomly distributed between the boxes by the epidemiologist. Only the epidemiologist is aware of the type of codes and the drugs were delivered to a specialist after randomization to reach the relevant patients. Randomization was simple and individual, Blinding description: This study is performed in a double-blind manner so that neither the physician nor the patients are aware of the contents of the sachets received by the patients based on the presence of probiotics or placebo. One group contains Lactobacillus reuteri and the other placebo and the doctor randomly give the patient a packet of the drug group. Finally, the results are reviewed and evaluated by the study evaluator by reviewing the collected data and equivalence with the package codes. 3 functional constipation in children. Intervention 1: Intervention group: includes 80 patients who are diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of probiotic Lactobacillus reuteri produced by Farabiotic Company(one sachet daily) plus polyethylene glycol as standard treatment and then next 28 days They only take probiotics. patients are generally treated with probiotics for 56 days and fills out a questionnaire form given to them by their doctor on a daily basis. Intervention 2: Control group: includes 80 patients diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of polyethylene glycol as standard treatment with placebo sachets Contains all the ingredients in the main sachets of our probiotic medicine except the probiotic itself. they take the main drug according to the instructions, and for the next 28 days, they consume only placebo sachets. In total, they use the placebo sachets produced by Farabiotic Company for 56 days as a control group and fill in the relevant questionnaire. Yes - There is a plan to make this available What will be shared: Data are collected in the form of a questionnaire When: After the intervention To whom: Qualified persons Conditions: Use for scientific advancement in the field under study Where to obtain: Clinical Office of Islamic Azad University, Medical Sciences of Tehran, Faculty of Pharmacy How to obtain: Clinical Office of Islamic Azad University, Medical Sciences of Tehran, Faculty of Pharmacy Comments:
public Maryam Shiehmorteza
No.99, Yakhchal street, Dr. Shariati Avenue
tehran Iran (Islamic Republic of) 1916893813 +98 21 2264 0056 shiehmorteza@iaups.ac.ir Islamic Azad University scientific Maryam Shiehmorteza
No.99, Yakhchal street, Dr. Shariati Avenue
tehran Iran (Islamic Republic of) 1916893813 +98 21 2264 0056 shiehmorteza@iaups.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) People with functional constipation according to ROME IV criteria Diagnosis of functional constipation should be based on a pediatric gastroenterologist Age range 3 to 18 years 3 years 18 years Both Having other underlying diseases History of allergies to the studied drugs and their accessories Use of any probiotics and prebiotics and laxatives other than study drugs and outside the study conditions K59.0 Constipation Treatment - Drugs Placebo Intervention group: includes 80 patients who are diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of probiotic Lactobacillus reuteri produced by Farabiotic Company(one sachet daily) plus polyethylene glycol as standard treatment and then next 28 days They only take probiotics. patients are generally treated with probiotics for 56 days and fills out a questionnaire form given to them by their doctor on a daily basis. Control group: includes 80 patients diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of polyethylene glycol as standard treatment with placebo sachets Contains all the ingredients in the main sachets of our probiotic medicine except the probiotic itself. they take the main drug according to the instructions, and for the next 28 days, they consume only placebo sachets. In total, they use the placebo sachets produced by Farabiotic Company for 56 days as a control group and fill in the relevant questionnaire. Stool stiffness. Timepoint: Stool stiffness is recorded daily in the questionnaire by individuals for 56 days. Method of measurement: Review by Bristol form and registration by the participant in the questionnaire form. Number of Painful stools. Timepoint: 56 days. Method of measurement: Daily record by individual. Stool incontinence. Timepoint: 56 days. Method of measurement: Daily record by individual. Abdominal pain. Timepoint: 56 days. Method of measurement: Daily record by individual. Appetite. Timepoint: 56 days. Method of measurement: Daily record by individual. Age. Timepoint: Before starting the intervention. Method of measurement: Registered by a pediatric gastroenterologist. Sex. Timepoint: Before starting the intervention. Method of measurement: Registered by a pediatric gastroenterologist. Duration of treatment. Timepoint: At the end of the study. Method of measurement: Registered by a pediatric gastroenterologist. Faradaro Fanavar Mehr Company Approved 2021-11-10 Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch Tehran Tehran Iran (Islamic Republic of)