Neonatal HyperbilirubinemiaNCT02807246
Effects of Probiotics on Neonatal Hyperbilirubinemia
A study testing Maflor®, Mamsel Pharmaceuticals, Turkey and drops of saline in people with Neonatal Hyperbilirubinemia, run by Karadeniz Technical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Maflor®, Mamsel Pharmaceuticals, Turkey and drops of saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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%
About this study
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.
Read the 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
- Neonatal Hyperbilirubinemia
- Being tested
- Maflor®, Mamsel Pharmaceuticals, Turkey, drops of saline
- Keywords
- Probiotic, Neonatal Hyperbilirubinemia
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maflor®, Mamsel Pharmaceuticals, TurkeyBiological
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 salineOther
Dietary Supplement: Breast milk +drops of saline
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | 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. Receives: Biological: Maflor®, Mamsel Pharmaceuticals, Turkey |
| Saline | Active comparator | Active Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics Receives: Other: drops of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Probiotic Support on Serum Bilirubin Levels
The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
Measured: Change from birth to ten days of life
Secondary outcomes (1)
Defecation frequency
Number of defecation frequency releated to treatment was evaluated and counted as times/a day.
Measured: Change from birth to ten days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Mutlu, MD, Karadeniz Technical University
- Investigators
- Yakup Aslan, Study chair, Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807246
- Sponsor's protocol ID
- 2014/115 24237859-120
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT02807246
- Acronym / sponsor ID
- 2014/115 24237859-120
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Probiotic, Neonatal Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Biological: Maflor®, Mamsel Pharmaceuticals, TurkeyExperimental: 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. |
| Saline | Active comparator | Other: drops of salineActive Comparator: Breast milk+five drops of saline The control group will be given Breast milk without the addition of probiotics |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maflor®, Mamsel Pharmaceuticals, TurkeyDietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey) Other Name: Maflor® | Biological | Probiotic |
| drops of salineDietary Supplement: Breast milk +drops of saline | Other | Saline |
Primary outcome
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.
1 secondary outcome
Defecation frequency
Time frame: Change from birth to ten days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yakup Aslan study chair
Division of Neonatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey
Questions about this trial
What is this clinical trial studying?
A study testing Maflor®, Mamsel Pharmaceuticals, Turkey and drops of saline in people with Neonatal Hyperbilirubinemia, run by Karadeniz Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Probiotic Support on Serum Bilirubin Levels (time frame: Change from birth to ten days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.