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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

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.

Condition or disease Intervention/treatment Phase
Neonatal Hyperbilirubinemia Biological: Maflor®, Mamsel Pharmaceuticals, Turkey Other: drops of saline Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Probiotics on Neonatal Hyperbilirubinemia
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807246


Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Study Chair: Yakup Aslan Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey

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Responsible Party: Mehmet Mutlu, MD, Assoc. Prof., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT02807246     History of Changes
Other Study ID Numbers: 2014/115 24237859-120
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mehmet Mutlu, MD, Karadeniz Technical University:
Probiotic
Neonatal Hyperbilirubinemia
Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Pathologic Processes
Infant, Newborn, Diseases