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IRCT20131004014882N7 IRCT 2019-09-08 Esfahan University of Medical Sciences Effect of prenatal administration of Lactobacillus Reuteri on prevention of Infantile Colic L. Reuteri (Lactobacillus Reuteri) comparison of the effectiveness of preinatal administration Lactobacillus Reuteri on prevention of Infantile Colic 2019-08-29 anticipated 174 Complete https://irct.ir/trial/40935 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Our goal is to give the pregnant mother the medicine at the end of pregnancy and its effect on the symptoms of colic in her infant after birth, Randomization description: We will use Random Allocation Software© Version 1.0, May 2004 in order to randomly arrange the patients into the two groups (L. Reuteri and placebo), using blocking and stratification methods. The physician who examines the infant (a pediatrics assistant) and the mothers will be blinded from the patient study groups. For randomization, patients will be handed a closed envelope and asked to deliver it to a gynecology and obstetrics assistant who then provides them the package containing the placebo (containing 9% glucose solution) or the probiotic drug (containing 100 million live L. Reuteri from Gostaresh Milad Pharmed® Prokid™ drop) dependent on the number existing in the envelope, Blinding description: The mothers and the pediatric assistant who will repeatedly examine the infants on account of infantile colic, are blinded from the treatment groups. 3 Infantile colic is an “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic.. Intervention 1: Intervention group: Mothers who receive probiotics:87 pregnant mother at the last 4 weeks of pregnancy enter to the study. The probiotic drug (containing 100 million live L. Reuteri from Gostaresh Milad Pharmed® Prokid™ drop). All patients were informed how and to use the medication (5 drops of the drug daily ) up to end of pregnancy. Intervention 2: Control group: placebo consumption: Control group treated with placebo drops (including sugar and carbohydrates), exactly the same as the original drug developed by Gostaresh Milad Poya Co., with 5 drops until delivery. 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 We have a very packed timetable, and we are afraid we cannot make the time for sharing the requested information.
public Dr. Fateme Famoori
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 fat.famoori@gmail.com Esfahan University of Medical Sciences scientific Dr. Mohamadali Pourmirzaei
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 pourmirzaei_1347@yahoo.com Isfahan univercity of medical science Iran (Islamic Republic of) The last 4 weeks of pregnancy The absence of a history of maternal immunocompromising conditions such as HIV The absence of maternal diabetes, hepatic and renal diseases, anemia (hemoglobin less than 10), bacterial or fungal infections, twins, maternal smoking history of 10 cigarettes per day, or administration of other probiotics Maternal age between 18 and 49 years old All pregnant mothers who have informed consent to participate in the study. 18 years 49 years Female Mother hypersensitivity to any component of drug Mothers who are not willing to continue pregnancy or who have had an early pregnancy due to complications of pregnancy Preterm labor Mothers who do not receive the drug properly K59.9 Functional intestinal disorder, unspecified Treatment - Drugs Placebo Intervention group: Mothers who receive probiotics:87 pregnant mother at the last 4 weeks of pregnancy enter to the study. The probiotic drug (containing 100 million live L. Reuteri from Gostaresh Milad Pharmed® Prokid™ drop). All patients were informed how and to use the medication (5 drops of the drug daily ) up to end of pregnancy. Control group: placebo consumption: Control group treated with placebo drops (including sugar and carbohydrates), exactly the same as the original drug developed by Gostaresh Milad Poya Co., with 5 drops until delivery. The severity of colic. Timepoint: From birth to 5 months. Method of measurement: For the assessment colic severity, we used a validated Iranian questionnaire previously suggested by Famoori et al. Infantile colic and severity. Timepoint: From birth to 5 months. Method of measurement: ِDefined by Wessel et al. and modified by ROME IV criteria as “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic. Prevention or reduction of severity of infantile colic. Timepoint: Birth to 5 months. Method of measurement: questionnaire. Esfahan University of Medical Sciences Approved 2019-02-18 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)