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

Indirect Hyperbilirubinemia Clinical Trial

Official title:

Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01411761
• Other study ID #: demirel9800
• Status: Recruiting
• Phase: Phase 4
• First received: August 5, 2011
• Last updated: August 5, 2011
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Gamze Demirel, MD
• Phone: +905324540156
• Email: kgamze[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Days

Eligibility

Inclusion Criteria:

• very low birth weight infants

Exclusion Criteria:

• chromosomal anomalies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Indirect Hyperbilirubinemia

Intervention

Dietary Supplement:
• Reflor
5 million unit/day, first 15 day of life

Other:
• serum physiologic
1 cc added to one feeding in a day

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration		6 months	Yes
Secondary	long term effect of S.boulardii on neurodevelopmental outcome		6 months	Yes