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IRCT20230816059167N1 IRCT 2023-08-21 Kashan University of Medical Sciences Investigating the effect of probiotics on neonatal jaundice Investigating the effect of probiotic supplements on hyperbilirubinemia in term neonates 2023-08-23 anticipated 81 Complete https://irct.ir/trial/72111 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly allocate patients among groups, first, the table of random numbers is extracted from the Stattrek website (https://stattrek.com/statistics/random-number-generator.aspx) and then these numbers are assigned to groups using the block randomization method, Blinding description: All three drops of Ramnoflor, Reuteflor, and placebo received from Fara Daru Fanavar Mehr (Farabiotic) company and prepared in packages with the same appearance and are coded (A, B, or C) by individuals who have no role in the study. During the study, the parents of the studied neonates and the researchers are blinded to the type of intervention. 3 Neonatal hyperbilirubinemia. Intervention 1: 1st Intervention group: Once daily and each time 5 drops of probiotic supplement containing Lactobacillus Reuteri prepared by Fara Daru Fanavar Mehr (Farabiotic) pharmaceutical company under the brand name Reuteflor. Each 5 drops of Reuteflor contains 8x(10^8) lyophilized active cells of Lactobacillus Reuteri. This drop does not contain ingredients of mother's milk. Intervention 2: 2nd Intervention group: Once daily and each time 5 drops of probiotic supplement containing Lactobacillus Rhamnosus prepared by Fara Daru Fanavar Mehr (Farabiotic) pharmaceutical company under the brand name Ramnoflor. Each 5 drops of Ramnoflor contains 8x(10^8) lyophilized active cells of Lactobacillus Rhamnosus. This drop does not contain ingredients of mother's milk. Intervention 3: Control group: Once daily and each time 5 drops of the placebo drop containing the base composition of probiotic drops without active ingredients. Placebo drops prepared by Fara Daru Fanavar Mehr (Farabiotic). 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 No further information
public Seyyed Ramin Madani
Shahid Beheshti Hospital, Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 drraminmadani@gmail.com Kashan University of Medical Sciences scientific Seyyed Ramin Madani
Shahid Beheshti Hospital, Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 drraminmadani@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) 35 to 42 weeks of gestation Birth weight between 10th and 90th percentile Newborns aged from birth to 14 days Hyperbilirubinemia based on Bhutani Nomogram 1 day 14 days Both Unwillingness to cooperate (lack of parental consent) Taking antibiotics Any acute or active infection Occurrence of any side effects Not consuming breast milk exclusively Thyroid disorders Presence of respiratory distress NICU admission Congenital heart disease The presence of hemolysis, hemoglobinopathies, and hemolytic blood diseases such as G6PD deficiency, blood group incompatibility Cephal hematoma and subgaleal hemorrhage Phenobarbital consumption by the mother in the last month of pregnancy Non-physiological hyperbilirubinemia Presence of a life-threatening congenital disorder Blood exchange Outpatient treatment P59.9 Neonatal jaundice, unspecified Treatment - Drugs Treatment - Drugs Placebo 1st Intervention group: Once daily and each time 5 drops of probiotic supplement containing Lactobacillus Reuteri prepared by Fara Daru Fanavar Mehr (Farabiotic) pharmaceutical company under the brand name Reuteflor. Each 5 drops of Reuteflor contains 8x(10^8) lyophilized active cells of Lactobacillus Reuteri. This drop does not contain ingredients of mother's milk. 2nd Intervention group: Once daily and each time 5 drops of probiotic supplement containing Lactobacillus Rhamnosus prepared by Fara Daru Fanavar Mehr (Farabiotic) pharmaceutical company under the brand name Ramnoflor. Each 5 drops of Ramnoflor contains 8x(10^8) lyophilized active cells of Lactobacillus Rhamnosus. This drop does not contain ingredients of mother's milk. Control group: Once daily and each time 5 drops of the placebo drop containing the base composition of probiotic drops without active ingredients. Placebo drops prepared by Fara Daru Fanavar Mehr (Farabiotic) Total Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum total bilirubin (mg/mL). Direct Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum direct bilirubin (mg/mL). Indirect Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum indirect bilirubin (mg/mL). Length of hospital stay. Timepoint: At the time of discharge. Method of measurement: Days. Defecation. Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: Number of defecations per day. Complications including allergic reactions, gastrointestinal complications and . Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: History taking and physical examination. Fara Daru Fanavar Mehr (Farabiotic) Kashan University of Medical Sciences Fara Daru Fanavar Mehr (Farabiotic) Approved 2023-07-16 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Pezeshk Boulevard, Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)