Clinical Trial: Effects of Probiotics on Neonatal Hyperbilirubinemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Probiotics on Neonatal Hyperbilirubinemia

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 Summary:

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.


Sponsor: Karadeniz Technical University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Karadeniz Technical University

Dates:
Date Received: June 8, 2016
Date Started: December 2014
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016