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Saccharomyces boulardii's efficiency on hyperbilirubinemia

Comparison of the efficiency of Saccharomyces boulardii on neonatal hyperbilirubinemia with placebo on late pereterm and term neonates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012123010279N2
Enrollment
150
Registered
2013-01-12
Start date
2012-07-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Neonatal hyperbilirubinemia. Neonatal jaundice from breast milk inhibitor

Interventions

Intervention 1: The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) during phototherapy. Intervention 2: The control group received placebo (dis
1 cc per dose twice daily) during phototherapy.
Treatment - Drugs
Placebo
The study group received Saccharomyces boulardii (Reflor®, Biocodex, France, 50 mg/kg per dose twice daily) during phototherapy.

Sponsors

Health Ministry Drug and Pharmacy General Management
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Late preterm (34, not completed week – 36, completed week) gestational weeks ) and term (= 37 gestational weeks) neonates 2. Newborns who need phototherapy for neonatal hyperbilirubinemia 3. Newborns who were 0-1 month old. Exclusion criteria: 1. Newborns who have congenital anomalies 2. Newborns who need intense phototherapy 3. Direct coombs positive ABO/Rh incompatability 4. Neonates who have sepsis/pneumonia during phototherapy 5. Neonates with hypothyroidism 6. Neonates who have gastrointestinal obstruction 7. Neonates with asphyxia 8. Contraindication of peroral feeding

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Phototherapy duration. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' medical records.;Maximum bilirubinemia level. Timepoint: Starts at the same time with the intervention. Method of measurement: Patients' laboratory records.

Countries

Turkey

Contacts

Public ContactFahri Ovali

Zeynep Kamil Maternity and Children Education and Training Hospital

fovali@yahoo.com80 06 391 216 90 00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026