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

Phase 4

• Conditions: Indirect Hyperbilirubinemia
• Interventions: Dietary Supplement: Reflor; Other: serum physiologic

• Registration Number: NCT01411761
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-06
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Last Update Submitted: 2011-08-05
• Study First Posted: 2011-08-08
• Last Update Posted: 2011-08-08
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• very low birth weight infants

Exclusion Criteria

• chromosomal anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saccharomyces boulardii	Reflor	study group
placebo	serum physiologic	serum physiologic

Primary Outcome Measures

Name	Time	Method
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration	6 months

Secondary Outcome Measures

Name	Time	Method
long term effect of S.boulardii on neurodevelopmental outcome	6 months

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology; 🇹🇷 Ankara, Turkey