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Effects of Probiotics on Neonatal Hyperbilirubinemia

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ClinicalTrials.gov Identifier: NCT02807246
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Mehmet Mutlu, MD, Karadeniz Technical University

Tracking Information
First Submitted Date  ICMJE June 8, 2016
First Posted Date  ICMJE June 21, 2016
Last Update Posted Date June 21, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Probiotics on Neonatal Hyperbilirubinemia
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Neonatal Hyperbilirubinemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Maflor®, Mamsel Pharmaceuticals, Turkey
  • Active Comparator: Saline
    Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
    Intervention: Other: drops of saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2016)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02807246
Other Study ID Numbers  ICMJE 2014/115 24237859-120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mehmet Mutlu, MD, Karadeniz Technical University
Study Sponsor  ICMJE Karadeniz Technical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yakup Aslan Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
PRS Account Karadeniz Technical University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP