Trials / Completed
CompletedNCT02807246
Effects of Probiotics on Neonatal Hyperbilirubinemia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Karadeniz Technical University · Academic / Other
- Sex
- All
- Age
- 1 Day – 10 Days
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2015-12-01
- Completion
- 2016-02-01
- First posted
- 2016-06-21
- Last updated
- 2016-06-21
Source: ClinicalTrials.gov record NCT02807246. Inclusion in this directory is not an endorsement.