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This study was designed as a prospective controlled study to investigate the effects of probiotic support started immediately after birth on newborn jaundice in breastfed babies born by normal spontaneous vaginal delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | 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. |
|
| Saline | Active Comparator | Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maflor®, Mamsel Pharmaceuticals, Turkey | Biological | Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor® |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Probiotic Support on Serum Bilirubin Levels | The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL. | Change from birth to ten days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Defecation frequency | Number of defecation frequency releated to treatment was evaluated and counted as times/a day. | Change from birth to ten days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yakup Aslan | Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey | Study Chair |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| drops of saline | Other | Dietary Supplement: Breast milk +drops of saline |
|
| D013568 | Pathological Conditions, Signs and Symptoms |