Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants

Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01315821

Enrollment

220

Registered

2011-03-15

Start date

2011-02-28

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

Necrotizing Enterocolitis, Very Low Birth Weight Infants

Keywords

Saccharomyces boulardii, necrotizing enterocolitis

Brief summary

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Detailed description

The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Interventions

DRUGSaccharomyces boulardii

5 million units/day for 3 months

DRUGPlacebo

Placebo for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 2 Months

Healthy volunteers

Inclusion criteria

* Very low birth weight infants \< 1500 gr

Exclusion criteria

* Genetic anomalies * Not willing to participate * Allergy to S. boulardii components

Design outcomes

Primary

Measure	Time frame
Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants	up to 6 months

Secondary

Measure	Time frame
Effect of Saccharomyces boulardii on culture proved sepsis	6 months
Effect of Saccharomyces boulardii on weight gain	up to 6 months
Effect of Saccharomyces boulardii on length of hospital stay	up to 6 months
Effect of Saccharomyces boulardii on mortality	up to 6 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactGamze Demirel, MD

kgamze@hotmail.com+903123065270

Backup ContactUgur Dilmen

Outcome results

None listed

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