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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 3

Conditions: Very Low Birth Weight Infants; Necrotizing Enterocolitis

Treatments: Drug: Saccharomyces boulardii; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01315821

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 1 day to 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Very low birth weight infants < 1500 gr

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Saccharomyces boulardii

Experimental group

Description:

Saccharomyces boulardii 5 million unit/day for 3 months

Treatment:

Drug: Saccharomyces boulardii

control

Placebo Comparator group

Description:

Placebo- for 3 months

Treatment:

Drug: Placebo