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

Phase 4 Study of Saccharomyces Boulardii on Indirect Hyperbilirubinemia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01411761
Enrollment
80
Registered
2011-08-08
Start date
2011-05-31
Completion date
2011-12-31
Last updated
2011-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indirect Hyperbilirubinemia

Keywords

indirect hyperbilirubinemia, very low birth weight infants

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.

Interventions

DIETARY_SUPPLEMENTReflor

5 million unit/day, first 15 day of life

1 cc added to one feeding in a day

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Days to 15 Days
Healthy volunteers
No

Inclusion criteria

* very low birth weight infants

Exclusion criteria

* chromosomal anomalies

Design outcomes

Primary

MeasureTime frame
Effect of S. boulardii on severity of hyperbilirubinemia and phototherapy duration6 months

Secondary

MeasureTime frame
long term effect of S.boulardii on neurodevelopmental outcome6 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactGamze Demirel, MD
kgamze@hotmail.com+905324540156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026