- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02807246
Effects of Probiotics on Neonatal Hyperbilirubinemia
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
|
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
Sponsor
Investigators
- Study Chair: Yakup Aslan, Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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