Clinical Trial: Prebiotics in the Prevention of Necrotizing Enterocolitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
Brief 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 Summary:
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.
Sponsor: Shaare Zedek Medical Center
Current Primary Outcome: Incidence of Necrotizing Enterocolitis [ Time Frame: yearly ]
Original Primary Outcome: Incidence of Necrotizing Enterocolitis
Current Secondary Outcome:
- fecal calprotectin, urine IFABP [ Time Frame: end of study ]
- NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] [ Time Frame: yearly ]
- Stool bifidobacteria [ Time Frame: End of study ]
Original Secondary Outcome:
- Reduced fecal calprotectin levels in the synbiotic group
- Reduced NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement] in those who do develop NEC from the synbiotic group, and
- Reduced NEC related mortality in the synbiotic group
Information By: Shaare Zedek Medical Center
Dates:
Date Received: February 8, 2007
Date Started: July 2009
Date Completion: July 2014
Last Updated: January 2, 2014
Last Verified: January 2014
