Effects of Probiotics on Neonatal Hyperbilirubinemia

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

Effects of Probiotics on Neonatal Hyperbilirubinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807246
• Other study ID #: 2014/115 24237859-120
• Status: Completed
• Phase: N/A
• First received: June 8, 2016
• Last updated: June 16, 2016
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

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®

Other:
• drops of saline
Dietary Supplement: Breast milk +drops of saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes