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Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants

This study is currently recruiting participants.
Verified June 2011 by Zekai Tahir Burak Maternity and Teaching Hospital
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01411761
First received: August 5, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Indirect Hyperbilirubinemia
 Dietary Supplement: Reflor
Other: serum physiologic
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • long term effect of S.boulardii on neurodevelopmental outcome [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saccharomyces boulardii
study group
 Dietary Supplement: Reflor
5 million unit/day, first 15 day of life
Placebo Comparator: placebo
serum physiologic
 Other: serum physiologic
1 cc added to one feeding in a day

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • very low birth weight infants

Exclusion Criteria:

  • chromosomal anomalies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411761

Contacts
Contact: Gamze Demirel, MD +905324540156 kgamze@hotmail.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology Recruiting
Ankara, Turkey, 06230
Contact: Gamze Demirel, MD     +905324540156     kgamze@hotmail.com    
Contact: Omer Erdeve, Assoc Prof            
Principal Investigator: Gamze Demirel, MD            
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Principal Investigator: Gamze Demirel, MD Zekai Tahir Burak Maternity Teaching Hospital
Study Director: Ugur Dilmen, Prof Zekai Tahir Burak Maternit Teaching Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01411761     History of Changes
Other Study ID Numbers: demirel9800
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
indirect hyperbilirubinemia
very low birth weight infants

Additional relevant MeSH terms:
Birth Weight
Hyperbilirubinemia
Body Weight
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013