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IRCT20150706023084N14 IRCT 2021-12-30 Faradaro Fanavar Mehr Company Evaluation of the probiotic effect of Lactobacillus reuteri in the treatment of chronic functional pain in children Evaluation of the effectiveness of Lactobacillus reuteri probiotics in the treatment of chronic functional abdominal pain in children aged 5 to 15 years 2022-01-21 anticipated 180 Complete https://irct.ir/trial/56534 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The identical packages of probiotic sachets or placebo (identified by codes 1 or 2) are randomly distributed among the people. The doctor randomly gives the patient a pack using the lottery method, 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. The packages are identified by codes that do not show the content. In the end, the analyzer, who is the only person who knows each code's meaning, reviews and evaluates the findings. 3 chronic functional abdominal pain in children. Intervention 1: Intervention group: Lactobacillus reuteri probiotic. 28 sachets One gram of probiotic is dissolved in sachets of water, yogurt or food (cold) every day and consumed for 28 days. Each sachet of 1 g of Reuteflor contains 300 mg of Lactobacillus reuteri lyophilized active cell (equivalent to 8 ^ 10 × 8 CFU). Other ingredients: maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator. Intervention 2: Control group: Lactobacillus reuteri placebo. 28 sachets One gram of placebo dissolves one sachet in water, yogurt or food (cold) every day and is consumed for up to 28 days. Each 1 gram placebo sachet contains maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator. 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
Yakhchal ,Shariati Street
Tehran Iran (Islamic Republic of) 646619395 +98 212640056 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) Abdominal pain is persistent or almost constant Pain has nothing to do with physiological events in the body (eating, defecation, menstruation, etc.) Some daily functions are lost The pain is not fake Symptoms to complete the criteria for other gastrointestinal functional disorders do not justify complete pain All of these criteria must be present for at least three months and the onset of symptoms at least six months before diagnosis 5 years 15 years Both The doctor determines that the child has chronic abdominal pain due to the consumption of a certain type of food (special diet) or a specific organic problem. Existence of an underlying disease that, according to the pediatric gastroenterologist, has caused abdominal pain. R10.4 Other and unspecified abdominal pain Treatment - Drugs Placebo Intervention group: Lactobacillus reuteri probiotic. 28 sachets One gram of probiotic is dissolved in sachets of water, yogurt or food (cold) every day and consumed for 28 days. Each sachet of 1 g of Reuteflor contains 300 mg of Lactobacillus reuteri lyophilized active cell (equivalent to 8 ^ 10 × 8 CFU). Other ingredients: maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator. Control group: Lactobacillus reuteri placebo. 28 sachets One gram of placebo dissolves one sachet in water, yogurt or food (cold) every day and is consumed for up to 28 days. Each 1 gram placebo sachet contains maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator. Intensity of pain. Timepoint: Every day for 28 days. Method of measurement: Based on oucher pain scale. Frequent pain. Timepoint: Every day for 28 days. Method of measurement: Record in the table. Duration of treatment. Timepoint: 28 days. Method of measurement: Check the questionnaire table. 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)