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Saccharomyces boulardii for prevention of necrotizing enterocolitis in preterm infants: a randomized, controlled
Gamze Demirel1, Omer Erdeve, Istemi Han Celik
1Neonatal Intensive Care Unit, Samsun Maternity and Child Health Hospital, Samsun, Turkey. kgamze@hotmail.com.
Insights
Saccharomyces boulardii (S. boulardii) supplementation did not reduce necrotizing enterocolitis (NEC) or death in very low-birth-weight (VLBW) infants. However, this probiotic improved feeding tolerance and decreased clinical sepsis risk.
Area of Science:
- Neonatal Medicine
- Gastroenterology
- Microbiology
Background:
- Necrotizing enterocolitis (NEC) is a severe gastrointestinal disease affecting premature infants.
- Probiotics, such as Saccharomyces boulardii (S. boulardii), are explored for preventing NEC in very low-birth-weight (VLBW) infants.
Purpose of the Study:
- To assess the efficacy of oral S. boulardii in reducing NEC incidence and severity.
- To evaluate the impact of S. boulardii on mortality, feeding intolerance, and sepsis in VLBW infants.
Main Methods:
- A prospective, randomized controlled trial involved VLBW infants (gestational age ≤32 weeks, birth weight ≤1500 g).
- Infants received either S. boulardii supplementation or a placebo.
- Primary outcomes included death or NEC (Bell's stage ≥2); secondary outcomes were feeding intolerance and sepsis.
Main Results:
- No significant difference in death or NEC incidence between the S. boulardii group (n=135) and the control group (n=136).
- Feeding intolerance was significantly lower in the probiotic group.
- Clinical sepsis incidence was significantly reduced in infants receiving S. boulardii.
Conclusions:
- Oral S. boulardii at 250 mg/day did not prevent NEC or reduce mortality in VLBW infants.
- S. boulardii supplementation demonstrated benefits in improving feeding tolerance.
- The probiotic intervention was associated with a reduced risk of clinical sepsis in this vulnerable population.
Aim:
To evaluate the efficacy of orally administered Saccharomyces boulardii (S. boulardii) for reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low-birth-weight (VLBW) infants.
Methods:
A prospective, randomised controlled trial was conducted in infants with gestational age ≤32 weeks and birth weight ≤1500 g. The study group received S. boulardii supplementation, and the control group did not. The primary outcomes were death or NEC (Bell's stage ≥2), and secondary outcomes were feeding intolerance and clinical or culture-proven sepsis.
Results:
A total of 271 infants were enrolled in the study, 135 in the study group and 136 in the control group. There was no significant difference in the incidence of death (3.7% vs. 3.6%, 95% CI of the difference, -5.20-5.25; p = 1.0) or NEC (4.4% vs. 5.1%, 95% CI, -0.65-5.12; p = 1.0) between the groups. However, feeding intolerance and clinical sepsis were significantly lower in the probiotic group compared with control.
Conclusion:
Although Saccharomyces boulardii supplementation at a dose of 250 mg/day was not effective at reducing the incidence of death or NEC in VLBW infants, it improved feeding tolerance and reduced the risk of clinical sepsis.
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