Effects of Probiotics on Neonatal Hyperbilirubinemia

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.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Maflor®, Mamsel Pharmaceuticals, Turkey

Biological

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

Other

Dietary Supplement: Breast milk +drops of saline

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Jun 21, 2016
Registry last updated: Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed