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Effects of Probiotics on Neonatal Hyperbilirubinemia

Primary Purpose

Neonatal Hyperbilirubinemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maflor®, Mamsel Pharmaceuticals, Turkey
drops of saline
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Hyperbilirubinemia focused on measuring Probiotic, Neonatal Hyperbilirubinemia

Eligibility Criteria

1 Day - 10 Days (Child)All SexesAccepts Healthy Volunteers

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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Probiotic

    Saline

    Arm Description

    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.

    Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Defecation frequency
    Number of defecation frequency releated to treatment was evaluated and counted as times/a day.

    Full Information

    First Posted
    June 8, 2016
    Last Updated
    June 16, 2016
    Sponsor
    Karadeniz Technical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02807246
    Brief Title
    Effects of Probiotics on Neonatal Hyperbilirubinemia
    Official Title
    Effects of Probiotics on Neonatal Hyperbilirubinemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karadeniz Technical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Hyperbilirubinemia
    Keywords
    Probiotic, Neonatal Hyperbilirubinemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Saline
    Arm Type
    Active Comparator
    Arm Description
    Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
    Intervention Type
    Biological
    Intervention Name(s)
    Maflor®, Mamsel Pharmaceuticals, Turkey
    Intervention Description
    Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor®
    Intervention Type
    Other
    Intervention Name(s)
    drops of saline
    Intervention Description
    Dietary Supplement: Breast milk +drops of saline
    Primary Outcome Measure Information:
    Title
    Effect of Probiotic Support on Serum Bilirubin Levels
    Description
    The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
    Time Frame
    Change from birth to ten days of life
    Secondary Outcome Measure Information:
    Title
    Defecation frequency
    Description
    Number of defecation frequency releated to treatment was evaluated and counted as times/a day.
    Time Frame
    Change from birth to ten days of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    10 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yakup Aslan
    Organizational Affiliation
    Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effects of Probiotics on Neonatal Hyperbilirubinemia

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