Effects of Probiotics on Neonatal Hyperbilirubinemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Probiotics on Neonatal Hyperbilirubinemia

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Biological: Maflor®, Mamsel Pharmaceuticals, Turkey
* Other: drops of saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A total of 150 full-term (gestational age ≥37 - <42 weeks) normal spontaneous vaginal delivery healthy newborns Birth weight between the 10th-90th percentiles Fed by breast milk only Exclusion Criteria: Newborns with familial hematologic disorders Having signs of hemolysis due to blood group incompatibilities Bleeding into closed spaces due to birth trauma complications (e.g. cephalohematoma) Suspected or documented neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection Perinatal and neonatal hypoxia Having thyroid dysfunction, respiratory distress or insufficiency, metabolic and thermoregulatory dysfunction, hemodynamic instability and congenital heart disease Maternal phenobarbital usage history during the last month of the pregnancy Having venous hematocrit (Htc) levels≥65%

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>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<br>* Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor®<br>|
| Active Comparator: Saline<br>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<br>* Dietary Supplement: Breast milk +drops of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Neonatal Hyperbilirubinemia