Effects of Probiotics on Neonatal Hyperbilirubinemia

Not Applicable

Completed

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Biological: Maflor®, Mamsel Pharmaceuticals, Turkey; Other: drops of saline

• Registration Number: NCT02807246
• Lead Sponsor: Karadeniz Technical University

Brief Summary

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

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-21
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Maflor®, Mamsel Pharmaceuticals, Turkey	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	drops of saline	Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics

Primary Outcome Measures

Name	Time	Method
Effect of Probiotic Support on Serum Bilirubin Levels	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.

Secondary Outcome Measures

Name	Time	Method
Defecation frequency	Change from birth to ten days of life	Number of defecation frequency releated to treatment was evaluated and counted as times/a day.