Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2014-12-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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®
Saline
Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics
drops of saline
Dietary Supplement: Breast milk +drops of saline
Interventions
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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®
drops of saline
Dietary Supplement: Breast milk +drops of saline
Eligibility Criteria
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Inclusion Criteria
* Birth weight between the 10th-90th percentiles
* Fed by breast milk only
Exclusion Criteria
* 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%
1 Day
10 Days
ALL
Yes
Sponsors
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Karadeniz Technical University
OTHER
Responsible Party
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Mehmet Mutlu, MD
Assoc. Prof.
Principal Investigators
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Yakup Aslan
Role: STUDY_CHAIR
Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
Other Identifiers
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2014/115 24237859-120
Identifier Type: -
Identifier Source: org_study_id
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