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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
220
5 million units/day for 3 months
Placebo for 3 months
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey (Türkiye)
RECRUITINGEffect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants
Time frame: up to 6 months
Effect of Saccharomyces boulardii on culture proved sepsis
Time frame: 6 months
Effect of Saccharomyces boulardii on weight gain
Time frame: up to 6 months
Effect of Saccharomyces boulardii on length of hospital stay
Time frame: up to 6 months
Effect of Saccharomyces boulardii on mortality
Time frame: up to 6 months
Ugur Dilmen
CONTACT
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