Indirect HyperbilirubinemiaPhase 4NCT01411761
Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants
A Phase 4 study testing Reflor and serum physiologic in people with Indirect Hyperbilirubinemia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Indirect Hyperbilirubinemia
- What is being tested?
- Reflor and serum physiologic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 4
- 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 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- very low birth weight infants
Who cannot join
- chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, 06230
Gamze Demirel, MD, +905324540156, kgamze@hotmail.com
Omer Erdeve, Assoc Prof
About this study
Official title: Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.
- Conditions
- Indirect Hyperbilirubinemia
- Being tested
- Reflor, serum physiologic
- Keywords
- indirect hyperbilirubinemia, very low birth weight infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflorDietary supplement
5 million unit/day, first 15 day of life
serum physiologicOther
1 cc added to one feeding in a day
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii | Experimental | study group Receives: Dietary Supplement: Reflor |
| placebo | Placebo comparator | serum physiologic Receives: Other: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
Measured: 6 months
Secondary outcomes (1)
long term effect of S.boulardii on neurodevelopmental outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gamze Demirel, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education HospitalUgur Dilmen, Prof, Study director, Zekai Tahir Burak Maternit Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411761
- Sponsor's protocol ID
- demirel9800
- Status last verified
- Jun 2011
- First submitted
- 5 Aug 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT01411761
- Acronym / sponsor ID
- demirel9800
- Conditions
- Indirect Hyperbilirubinemia
- Keywords
- indirect hyperbilirubinemia, very low birth weight infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 8 Aug 2011 (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.
Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii | Experimental | Dietary Supplement: Reflorstudy group |
| placebo | Placebo comparator | Other: serum physiologicserum physiologic |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- very low birth weight infants
Key exclusion criteria (1 listed)
- chromosomal anomalies
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 |
|---|---|---|
| Reflor5 million unit/day, first 15 day of life | Dietary supplement | Saccharomyces boulardii |
| serum physiologic1 cc added to one feeding in a day | Other | placebo |
Primary outcome
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration
Time frame: 6 months
1 secondary outcome
long term effect of S.boulardii on neurodevelopmental outcome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
Related trials for Indirect Hyperbilirubinemia
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
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Recruiting
The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
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COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
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Not yet recruiting
Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
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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.
Gamze Demirel, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
Ugur Dilmen, Prof study director
Zekai Tahir Burak Maternit Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reflor and serum physiologic in people with Indirect Hyperbilirubinemia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Demirel, MD (+905324540156, kgamze@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration (time frame: 6 months). 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 8 Aug 2011.