Effects of Probiotics on Neonatal Hyperbilirubinemia

June 16, 2016 updated by: Mehmet Mutlu, MD, Karadeniz Technical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
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

Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey)

Other Name: Maflor®
Active Comparator: Saline
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
Dietary Supplement: Breast milk +drops of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from birth to ten days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from birth to ten days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Study Chair: Yakup Aslan, Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/115 24237859-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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