NCT00437567

Prebiotics in the Prevention of Necrotizing Enterocolitis

Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

Summary

Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of \<1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

Detailed description

Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls. Preterm neonates, \<1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Galacto-oligosaccharide (GOS)	Treatment group to receive 1.3 gm/kg/day GOS from initiation of enteral feeds until 35 weeks post-conceptual age.
OTHER	Placebo	Similar quantity of sterile water to be added to milk

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2007-02-21
• Last updated: 2014-01-03

Locations

1 site across 1 country: Israel