Effects of Probiotics on Neonatal Hyperbilirubinemia
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|ClinicalTrials.gov Identifier: NCT02807246|
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hyperbilirubinemia||Biological: Maflor®, Mamsel Pharmaceuticals, Turkey Other: drops of saline||Not Applicable|
Objectives: Enterohepatic circulation of bilirubin imposes an extra burden of approximately 30% on total serum bilirubin levels. Intestinal microflora is the main factor affecting enterohepatic circulation. This study investigated the effects of probiotic support started immediately after birth on neonatal hyperbilirubinemia in babies born by normal spontaneous vaginal delivery and breastfed only.
Methods: A total of 150 healthy term newborns were included in the study and allocated in the study and control groups. Immediately after birth, newborns in the study group received probiotic in liquid drop form (Maflor® drops containing Lactobacillus Rhamnosus GG 109 Colony Forming Units(CFU), Mamsel Pharmaceuticals, Turkey), at a dose of 5 drops a day orally for 10 days. Newborns in the control group received 5 drops of saline solution per day orally, instead. In addition to routine biochemical examinations;serum bilirubin levels in the cord blood, and blood samples of the newborns on the 3rd, 5th and 10th days of birth were measured in all subjects in both groups. Defecation frequency was recorded for all subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Probiotics on Neonatal Hyperbilirubinemia|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2016|
Active Comparator: Probiotic
Experimental: Breast milk+ Probiotics(Maflor®, Mamsel Pharmaceuticals, Turkey) The study group will be fed with probiotics at a dose of 1x109 CFU/day (Lactobacillus rhamnosus GG 109colony ). Probiotic is in a liquid drop form at a dose of 5 drops a day and is used orally for 10 days.
Biological: Maflor®, Mamsel Pharmaceuticals, Turkey
Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey)
Other Name: Maflor®
Active Comparator: Saline
Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
Other: drops of saline
Dietary Supplement: Breast milk +drops of saline
- Effect of Probiotic Support on Serum Bilirubin Levels [ Time Frame: Change from birth to ten days of life ]The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
- Defecation frequency [ Time Frame: Change from birth to ten days of life ]Number of defecation frequency releated to treatment was evaluated and counted as times/a day.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807246
|Study Chair:||Yakup Aslan||Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey|